Be a Part of Something Xceptional

AsclepiX Careers

At AsclepiX Therapeutics, we are united by a singular focus on revolutionizing the treatment of retinal disease and cancer. We are seeking Xceptional individuals to join our team who share our vision and commitment to innovate and discover new therapies that have the potential to improve the lives of patients worldwide.

Life at AsclepiX

At AsclepiX, the work is meaningful, the culture is inclusive, the company growth is rapid, and the rewards are plentiful. Join us!

We support a vibrant lifestyle, striving to provide optimal work-life balance. You will be amazed by your own potential when immersed in our mission driven culture and supported by your new colleagues. We consider our employees to be our most valuable resource. Nothing is more important to our success than the scientific and operational excellence each of our team members contributes. We have a competitive advantage that is enjoyed by no other organization because of the courage, creativity and commitment of our employees that cannot be surpassed.

AsclepiX Virtual Team Meeting
Asclepix Team Meeting

Current Openings

Human Resources Manager

Job ID#: HR-001
Location: NJ
Posting Date: July 2020

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Job Description:

The Human Resources (HR) Manager will be a key member of the HR and leadership team and along with the Business Support Manager, he/she will lead the execution of HR strategy to support the achievement of AsclepiX’s business goals working hand in hand with the Business Support Manager. A highly results oriented and detailed professional is needed with a strong acumen toward the development of HR systems and processes that support a fast paced, high growth and entrepreneurial company. 

Duties and Responsibilities:

  • Plans, organizes, and implements key programs and initiatives to optimize AsclepiX’s human resource function and drive exceptional business results
  • Works to ensure alignment and execution of operational HR delivery including but not limited to talent acquisition, compensation and benefits, payroll, culture, employee relations and HR operations delivery across HR value delivery
  • Assists the Business Support Manager in translating the strategic and tactical business plans into HR operational plans
  • Assists in Talent Acquisition to ensure Recruitment tracking, Calendarized Staffing and Recruiter Tracking is completed, and relevant dashboards maintained regarding cost of hire, time to hire etc. and overall recruitment effectiveness and efficiency
  • Assists the Business Support Manager to ensure the effective running of the annual performance review and calibration processes, identifying promotable and high potential employees and supporting the development of plans for all performance category employees
  • Contributes towards the development and implementation of progressive and proactive compensation and benefits programs to provide motivation, incentives and rewards for effective performance
  • Manages all HR reporting always looking for ways to optimize the system capabilities
  • Develops and executes programs to allow the organization to embrace applicants and employees of all backgrounds ensuring all regulatory tracking is completed
  • Timely processes all New Hire background checks
  • Responsible for the effective implementation of an HRIS system in the future that is fit for purpose and scalable as the organization grows and ensures data integrity and accuracy of records
  • Leads AsclepiX’s on-boarding process to ensure all employees join/integrate consistently and well with a great start working closely with hiring managers
  • Ensures the delivery of metric/dashboards to evidence the effectiveness of all programs and practices
  • Assists in the development appropriate policies and programs for effective management of the people resources of the organization
  • Enhances and/or develops, implements, and enforces HR policies and procedures of the organization by way of systems that will improve the overall operation and effectiveness of the organization.
  • Provides technical advice and knowledge to others within the human resource discipline.
  • Perform other duties as assigned

The duties and responsibilities as listed in this job description are not exhaustive and additional responsibilities may be assigned based on business needs and clinical study status with little or no prior notice.

Qualification Requirements:

Education and Experience:

  • 5 – 7+ years HR experience, including Life Sciences sector experience (E)
  • 5+ years business partnering experience at the leadership team level (E)
  • Relevant business/HR qualifications (e.g. MBA or PHR qualification) (P)
  • Experience of organizational build in a complex high growth environment (E)
  • Experience of implementing fully integrated HRIS systems across multi-site environments (E)
  • Ability to roll up your sleeves and get things done and done well (E)
  • Trustworthy (E)
  • High Integrity & Ethics (E)
  • High degree of Humility (E)
  • Alignment to All AsclepiX Values (E)

(E) – Essential (P) – Preferred

Knowledge, Skills and Abilities:

  • Strong Business Acumen
  • Focus on Delivery and Strong Results Orientation
  • Must have excellent written and verbal communication skills and interpersonal skill. Normally receives no instruction on routine work, general instruction on new assignments.
  • Works on assignments that are complex in nature where good judgment and discretion is required in resolving problems
  • Requires the ability to be flexible, proactive, and able to practice excellent prioritization
  • Ability to work in a high-paced environment and exceptional detail orientation
  • Demonstrates good analytical, organizational abilities and consultation skills
  • Strong computer skills – MS Word, Excel, PowerPoint, Outlook, SharePoint

Physical Demands and Work Environment:

  • The physical demands of the position are normally associated with extended amounts of time in front of a computer
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Must be willing to travel (domestic ~ 20%). This includes intercompany office travel as requested.

AsclepiX Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.

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Sr. VP/VP Regulatory Affairs (RA) and Quality Assurance (QA)

Job ID#: RA-001
Location: Field/NJ/Maryland
Posting Date: July 2020

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Job Description:

The Senior Vice President/Vice President of Regulatory Affairs (RA) & Quality Assurance (QA) is responsible for directing the AsclepiX’s global regulatory and quality assurance strategies. The Sr. VP/VP establishes the organization’s goals and objectives regarding regulatory affairs and quality assurance and ensures they are achieved. This individual is responsible for leading all submissions and communications with regulatory authorities and managing international submissions and responses. Additionally, this individual will drive the activities of the quality assurance program with a view towards phase-appropriate documentation, developing and managing internal training and SOPS, continuous improvement, and implementation of corrective and preventive actions.

In this role, the Sr. VP/VP ensures that documentation requirements for products and processes are established through change control and assures ongoing maintenance of the QA System. This individual has the overall responsibility for managing required resources, overseeing a significant budget, and meeting regulatory submission schedule necessary to ensure the effective fulfillment of corporate goals and objectives. He/she will partner with key stakeholders to ensure they are tied into regulatory and quality assurance strategies and execution.

Duties and Responsibilities:

  • Manages the preparation and reviews submissions to the FDA and other global health authorities
  • Manages international regulatory submission requirements, including the day-to-day responsibilities of regulatory submissions
  • Provides guidance and recommendations to key stakeholders within the organization and monitors compliance with regulatory and quality assurance requirements and commitments
  • Coordinates responses and interactions between the company and regulatory agencies on matters relating to AsclepiX’s product regulatory submissions
  • Leads the Quality Assurance program to develop and maintain appropriate SOPs for a clinical stage development company, to oversee training of all relevant personnel, and to ensure that quality objectives are being met
  • Maintains up-to-date knowledge and understanding of regulatory requirements and concerns that affect the company and communicates changes to relevant personnel
  • Organizes and promotes company-wide quality system improvement efforts
  • Leads strategies for an effective document control system
  • Keeps leadership apprised on the status, objectives, risks, and mitigation plans associated with the various internal projects, as well as ensures regulatory teams are aware of current integrated program timelines
  • Remains current with regulatory intelligence and ensures submissions are aligned with current standards/expectations
  • Demonstrates expert knowledge of submission or technology-related global Health authority guidelines/regulations
  • Act as regulatory contact and strategist with the FDA, international regulatory agencies, and other regulatory bodies.
  • Lead, and direct Quality Operations in driving compliance activities related to FDA regulations, and quality systems standards.
  • Provide regulatory oversight for product development, manufacturing, and product expiry/retest
  • Provide overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally
  • Coordinate the review and approval of product labeling
  • Identify issues early in the submission process that could potentially impact product development
  • Determine submission requirements and coordinate plans and timelines with Project Management
  • Evaluate risks and safety issues and recommend regulatory solutions during the clinical phase
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approvals
  • Organize, prepare, and review FDA applications and other regulatory documents, including clinical study protocols/data and CMC
  • Monitors regulatory outcomes and provides input and advice to Senior Management Team
  • Leads organization through regulatory due diligence
  • Keeps ahead of domestic and international regulatory requirements and changes within the regulatory registration processes
  • Lead the RA/QA organization to foster best in class in talent and operating practices
  • Work in close alignment with R&D, Clinical, manufacturing and compliance functions

Additional Dimensions:

  • Must be able to work internally with all levels of the Company as well as externally with Consultants, Vendors and Agents.
  • Ensure that RA/QA organization complies with all policies and standards.
  • Ensure that all Corporate HR Policies and Programs are effectively implemented and respected by all colleagues in order to attract, retain, and develop talent.
  • Champion AsclepiX’s Core Values across the organization and challenges the team to subscribe to them.
  • Ensure the RA/QA organization operates to the highest standards of business ethics and quality standards.

The duties and responsibilities as listed in this job description are not exhaustive and additional responsibilities may be assigned based on business needs and clinical study status with little or no prior notice.

Qualification Requirements:

Education, Experience, Knowledge, Skills and Abilities:

  • 20+ years’ experience in Pharmaceutical QA and Regulatory Affairs
  • Five to ten years’ experience in managing personnel and complex activities. These should include experience in quality management.
  • PharmD or PhD preferred; Bachelor’s degree required
  • Proven ability in leading and directing regulatory affairs, compliance, and quality assurance activities.
  • Ophthalmology/Oncology/Peptide experience is preferred
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Excellent communication, analytical and organizational skills
  • Ability to provide vision and leadership
  • Demonstrated ability to interface and maintain effective relationships with all levels of employees in a team-oriented environment.
  • Excellent interpersonal skills.
  • Effective communication skills and team participation skills.
  • Have a comprehensive and disciplined approach to risk management and regulatory compliance through an intimate understanding of processes and systems, a network of appropriate contacts, and an in-depth knowledge of the internal operations and mentality of the FDA and other health authorities.
  • Experience working with global regulatory processes
  • A comprehensive understanding of the industry’s complex legal and regulatory requirements is essential

Physical Demands:

  • Standard physical demands: sitting at desk, working at computer

Work Environment:

  • Standard office environment, multiple floors with stairs.
  • Travel required.
  • To perform this job successfully, and individual must be able to perform each essential duty satisfactorily.  The requirements listed above are representative of the knowledge, skills and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

AsclepiX Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.

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Director/Sr. Manager, Clinical Monitoring

Job ID#: CO-003
Location: Field-Based
Posting Date: May 2020

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Job Description:

The Director/Sr. Manager of Clinical Monitoring works closely with the study project team and Clinical Research Associates (CRAs) to lead the delivery of site management clinical operations activities for all phases of project lifecycles; holds direct reports and other team members accountable for high performance while promoting engagement and fostering collaborative relationships and a culture of accountability.

Duties and Responsibilities:

  • Responsible for the supervision and administrative oversight of direct reports (e.g., CRAs). Develops training plans and assures training compliance for all direct reports. Completes performance reviews and implements performance development plans; conducts supervisory visits with direct reports. Meets regularly with direct reports to mentor and to evaluate workload and metrics compliance. Evaluate direct report’s competency to perform on-site visits. Collaborates with study management / leadership team to identify project resourcing demands and resolves potential resourcing conflicts including staff turnover. Provides feedback to leadership team on areas of process improvement. Participates in interviewing potential candidates; assess induction training needs and orients and trains new hires into the company and study teams.
  • Reviews scope of work, budget and protocol content. Conducts resource planning, budget forecasting and accruals reporting and invoice approval. Provides training to monitoring teams on protocol, case report form completion, Standard Operating Procedures (SOPs), clinical plans and guidelines and oversee timelines for studies.
  •  Develops clinical monitoring plans and assist with the development of clinical plans and guidelines; manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Leads project calls with CRAs; responsible for study site assignments; ensures study-specific training requirements are completed and documented. Provides assistance and/or co-monitoring for high-enrolling or non-enrolling sites and issues resolution
  •  Collaborates with project team members and CRO as applicable to assure timely site initiation process. This includes but is not limited to the following: Facilitates the site identification, selection and feasibility process, assist Clinical Trial Manager (CTM) with tracking of site initiation process that includes Institutional Review Board (IRB) submission and approvals, scheduling of initiation visits to coincide with shipment of clinical supplies
  • Review site visit reports (all visit types) per SOPs and respective monitoring plan, assures compliance with monitoring intervals and metrics per project requirements; identifies any clinical site or monitor issues and trends and implements mitigation and solutions/corrective actions as needed
  • May act as back-up to CRA team to perform site monitoring visits
  • Provides support and oversees in the monitoring aspect in the planning of quality assurance activities and assist with coordination of audit findings / CAPAs resolution and communicating proactively with QA representatives regarding ongoing resolution activities
  • Provides outsourcing services in support of study teams and functional groups to include Request for Proposal (RFP) process, service provider identification, selection, bid presentation, bid analysis, vendor assessment visit, contract development, change orders and issues management
  • Interacts with members of the cross-functional study team; frequent interactions with both internal and external personnel; manage 3rd party vendors (e.g. CRO)
  • Attends meetings: Vendor kick-off meetings, Investigator Meetings, industry conferences
  • Contributes to the development and maintenance of policies, SOPs and associated documents

The duties and responsibilities as listed in this job description are not exhaustive and additional responsibilities may be assigned based on business needs and clinical study status with little or no prior notice.

Qualification Requirements:

Education, Experience, Knowledge, Skills and Abilities:

  • Bachelor’s degree, preferably in scientific and health-related discipline. An equivalent combination of relevant education and applicable job experience may be considered
  • Minimum of 10 years prior experience in clinical research at a managerial level with field monitoring experience required; previous experience as a lead CRA or project management role coordinating clinical operations activities desired
  • Requires previous supervisory/line management experience
  • Proficient knowledge of GCP-ICH guidelines, FDA regulations, other regulatory requirements as necessary as well as basic understanding of the phases of clinical development and medical terminology
  • Ophthalmology knowledge is strongly desired but not required
  • Knowledge and experience in clinical monitoring and site management
  • Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making
  • Strong interpersonal skills with ability to communicate persuasively and with clarity, be flexible and adaptable to changing requirements; be resourceful and creative. Demonstrates team building, motivating, mentoring and influencing
  • Strong planning and organizational skills; possess high level of flexibility in a dynamic environment. Able to multi-task, attention to detail and prioritize appropriately, works well under high-pressure environment to meet deadlines/tight schedules
  • Strong professional maturity and wisdom to work through challenges and push through issues to reach mutual outcomes across teams, functional departments, vendors
  • Strong decision-making skills, judgment, problem solving, initiative and accountability
  • Self-direction and self-motivated
  • Knowledge of hiring, supervision, coaching and evaluation of staff required
  • Requires computer literacy in several software packages, especially Microsoft Office applications and database software

Physical Demands:

  • The physical demands of the position are normally associated with extended amounts of time in front of a computer.
  • Ability to travel (up to 30%). This includes intercompany office travel as requested.

Work Environment:

  • Field-based
  • Standard office environment, 25 floors with stairs
  • To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

AsclepiX Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.

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Director, Clinical Research

Job ID#: CR-001
Location: Field-based
Posting Date: April 2020

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Job Description:

The Director Clinical Research is responsible for the planning, design, interpretation and dissemination of clinical studies for all phases of clinical development at high quality and in a time effective manner in line with the department and corporate goals and within regulatory guidelines. The Director Clinical Research will collaborate with Clinical Operations for study implementation and execution. Responsibilities may include recruiting clinical investigators, selecting CROs, adverse event reporting and safety data review in collaboration with Medical Monitor.

Duties and Responsibilities:

  • Support the Vice President, Clinical Research in providing medical input into the design of the clinical development program, strategic and tactical plans for investigational products in all phases of development
  • Lead the development of clinical trial protocols, investigator brochures, and other documents required to conduct clinical trials
  • Conduct investigator meetings and host wet lab, visit study sites to observe the procedures and discuss clinical study protocol with investigators, develop effective working relationship with investigators and key opinion leaders
  • Collaborate with Clinical Operations in CRO selection, investigator selection, analysis of patient recruitment strategies, milestones, data collection and analysis, and ensure all clinical study activities are completed in accordance with applicable regulations and guidance, ICH GCP, and SOPs
  • Oversee safety, including the review of SAEs and safety data in collaboration with Medical Monitor; ensure that sites and regulatory agencies are notified and regulatory procedures are compliant
  • Review clinical data from all phases of development and support study reports writing and publications
  • Support clinical sections of INDs, NDA’s and other regulatory submissions

The tasks and duties listed above are not exhaustive and additional responsibilities may be assigned as needed with little or no prior notice.

Qualification Requirements:

Education and Experience:

  • Advanced Scientific degree required (MD, OD, PharmD, PhD)
  • Minimum 6 years of experience in the biotechnology / pharmaceutical industry with at least three years of hands-on clinical development experience
  • Experience in Ophthalmology retinal drug development/medical affairs highly preferred

Knowledge, Skills & Abilities:

  • Knowledge of FDA and other regulatory requirements, ICH guidelines, as well as understanding of all phases of drug clinical development
  • Thorough knowledge of clinical medicine and clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing)
  • Strong interpersonal skills and excellent verbal and written ability
  • Strong project planning, leadership, and negotiation skills as well as an ability to contribute creative yet practical solutions to problems
  • Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation of the trial and resolve the issues in a timely fashion
  • Ability to forge cross-functional working relationships with internal teams and external project partners
  • Self-direction and self-motivated

Physical Demands

The physical demands of the position are normally associated with extended amounts of time in front of a computer. Travel will be required (approximately 50%).

Work Environment

Standard office environment, 25 floors with stairs
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

AsclepiX Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.

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Sr. Clinical Trials Manager

Job ID#: CO-001
Location: Jersey City, New Jersey
Posting Date: April 2020

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Job Description:

The Sr. Clinical Trials Manager (CTM), in collaboration with the Sr. Director/Director, Clinical Operations is responsible for the oversight and execution of AsclepiX clinical trials to ensure completion of study deliverables, proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required; will assist with the planning, execution and completion of clinical studies within agreed upon timeframes and budget and in compliance with the currently approved protocol, ICH-GCP regulations as well as company Standard Operating Procedures (SOPs).

Duties and Responsibilities:

  • Manages all clinical aspects of a study, that includes assessment of operational feasibility and recommends study execution plan; develops and manages comprehensive study timelines and metrics, budgeting and project deliverables; plans, executes, and leads study-specific meetings (e.g., team meetings, vendor meetings, investigator meetings)
  • Manages all clinical aspects of a study, that includes assessment of operational feasibility and recommends study execution plan; develops and manages comprehensive study timelines and metrics, budgeting and project deliverables; plans, executes, and leads study-specific meetings (e.g., team meetings, vendor meetings, investigator meetings)
  • Prepares and presents project debriefings, as required and provides timely updates on progress and changes in scope, timelines and resources
  • Provides operational and strategic input into study documents; works with the study team to design clinical trial protocols consistent with the clinical development plan, ICF and develop an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met
  • Prepares and/or reviews both study-related and study site documents which may include but not limited to the following: Monitoring Plan, Laboratory Manual, Pharmacy Manual, Project Management Plan, CRF Completion Guidelines, site specific informed consent, study tools/worksheets/source, site contracts/budgets/payments
  • Plans for and manage materials to support execution of clinical studies including but not limited to distribution of documents, forms, supplies, equipment, etc.
  • Participates in set-up and testing of specifications from external vendor systems (e.g. EDC, lab vendor, reading center)
  • Performs study risk management and implement mitigations; identify potential study issues, recommends and implement solutions and corrective actions, as needed
  • Provides outsourcing services in support of Project Teams and functional groups, to include the Requestfor Proposal (RFP) process, service provider identification, selection, bid presentation, bid analysis, vendor assessment visit, contract development, change orders and issue management
  • Develops and manages study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget. Provides Finance with activity forecasts to allow for appropriate accrual
  • Develops subject recruitment/retention strategy and any related initiatives, tracks and reports study metrics
  • Ensures investigational product and other clinical supplies are provisioned appropriately with proper associated documentation for each clinical site
  • Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and SOPs: supports and oversees in the planning of quality assurance activities and coordinates resolution of audit findings / CAPAs; ensures audit-ready condition of clinical trial documentation including central clinical files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate
  • Oversight of Trial Master File set-up, maintenance, ongoing quality review and final reconciliation of study documents
  • Manages clinical monitoring activities, ensuring compliance with Good Clinical Practices (GCP) and applicable regulations; participates in site monitoring visits as appropriate
  • Coaches and provides guidance to clinical operation staff; facilitate sharing of best practices and product knowledge within the function
  • Interact with members of the cross-functional study team; frequent cross-functional interactions with internal and external personnel (e.g., regulatory affairs, medical/safety, investigators, CROs, vendors, etc.)
  • Contribute to the development and maintenance of policies, SOPs and associated documents and to process improvement efforts, as required

The tasks and duties listed above are not exhaustive and additional responsibilities may be assigned as needed with little or no prior notice.

Qualification Requirements:

Education and Experience:

  • Bachelor’s degree, preferably in scientific discipline. An equivalent combination of relevant education and applicable job experience may be considered
  • Minimum of 7 years prior experience as a manager of clinical studies or industry related project management

AsclepiX Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.

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Clinical Trials Associate

Job ID#: CO-002
Location: Jersey City, New Jersey
Posting Date: April 2020

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Job Description:

The Clinical Trials Associate (CTA) provides support to the (Sr.) Clinical Trials Operations Manager and in some cases the Clinical Research Associates (CRAs) in the conduct of clinical trials and in the management of investigational study sites to ensure compliance with study timelines, study protocols, ICH-GCP and applicable regulatory requirements as well as company Standard Operating Procedures (SOPs).

Duties and Responsibilities:

  • Serves as primary contact for investigative study sites on assigned studies
  • Performs investigator recruitment activities via telephone calls or written communications and assist in the conduct of feasibility collection for study site assessment and qualification
  • Performs activities relating to essential document collection, review, maintenance and reconciliation ensuring documents from both sponsor and investigative study sites follow ICH-GCP guidelines and applicable local regulatory requirements, tracks site readiness
  • Provides support to investigative study sites with fulfilling obligations with regards to local submissionsas per local IRB/IEC requirements; responsible for central IRB/IEC study submission of regulatory documents package
  • Proficient in the development and review of informed consent form templates to ensure required elements are present
  • Participates in meetings – internal, project-related, vendor – and acts as notetaker
  • Plans for and manage materials to support execution of clinical studies including but not limited to creation, distribution and tracking of investigational documents, forms, supplies, equipment, etc.;ensures investigational product and other clinical supplies / tools are on-site timely with proper associated documentation
  • Assist in the creation, review and maintenance of clinical study documents which may include but not limited to the following: Monitoring Plan, Laboratory Manual, Pharmacy Manual, Project Management Plan, CRF Completion Guidelines, site specific informed consent, study tools/worksheets/source
  • Participates in set-up and testing of specifications from external vendor systems (e.g. EDC, labvendor, reading center)
    Assist in the preparation and attendance of investigator meetings and may present, as requested; support outsourcing services to include attendance at vendor bid defenses and provide vendor assessment
  • Assist in the preparation and attendance of investigator meetings and may present, as requested; support outsourcing services to include attendance at vendor bid defenses and provide vendor assessment
  • Provides timely project status updates, reports and data as requested for performance and project status metrics for assigned studies; documents and tracks protocol-related questions and answers
  • Assist in the development of subject recruitment/retention strategy and any related initiatives, tracks and reports study metrics
  • Provides support to the CRAs to ensure study sites’ timely completion of electronic case report forms and query resolution in accordance with study-specific clinical and data management plans; assist with clinical data listings review to ensure detection of issues or data trends are identified early and mitigation/resolution implemented to maintain data integrity
  • Responsible for the Trial Master File set-up, maintenance, ongoing quality review and final reconciliation of study documents; participates in TMF and audits as requested and responds to less complex findings without oversight and with guidance for more complex or serious findings
  • Assists with oversight of study vendors; Interacts with study vendors and other AsclepiX functional areas as secondary project contact for issues and questions
  • Contribute to the development and maintenance of policies, SOPs and associated documents and to process improvement efforts within and across functional areas, as required
  • May mentor or train less experienced team members

 

The tasks and duties listed above are not exhaustive and additional responsibilities may be assigned as needed with little or no prior notice.

Qualification Requirements:

Education and Experience:

  • Bachelor’s degree, preferably in scientific discipline. An equivalent combination of relevant education and applicable job experience may be considered
  • Minimum 3-4 years of clinical study-start-up experience

AsclepiX Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.

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