Clinical Project Manager II (Remote)

The Clinical Project Manager II is responsible for the planning, execution, and finalization of clinical trial projects according to timelines, budget, and scope in compliance with applicable rules and regulations. The Clinical Project Manager II will be the main liaison between project team members, vendors/contractors, and client/sponsor representatives.

This role is generally assigned to low to high complexity trials.

Depending on the details of the organization and/or the scope of work for a project, which is contracted to by the sponsor, a project manager may only oversee a selection of the duties below during an assigned project. A project manager may work in one or several projects at the same time.

Summary Of Essential Duties And Responsibilities

Major duties during the cost proposal process

• Contributes to the initial planning during the cost proposal phase and may participate in the bid-defense meeting for clinical trials.
• Contributes to definition of project scope, goals, and deliverables in collaboration with sponsor, senior management, and other relevant stakeholders.

Major Duties During The Project Set-up Phase

• Acts as primary point of contact for considerations of the sponsor and ensures that sponsor interests are met (within the framework of the contractual and regulatory stipulations).
• Understands protocol, product specifications, and retains general knowledge of therapeutic area in sufficient detail to be able to advise and discuss with project team members and trial site personnel.
• Delegates work to assigned study team and monitors their progress to ensure deliverables are being met.
• Schedules internal and sponsor kick-off meetings with appropriate team members; ensuring that roles and responsibilities are clear and documented.
• Effectively communicates and continually manages project objectives and goals with team members and sponsor and other third parties, as appropriate.
• Develops Project Management Plan and any other study management plans.
• Determines needs for involvement of vendors and study equipment requirements.
• Participates in site selection including feasibility evaluation.
• Familiar with IP needs for project (IP packager/labeler, shipping, storage, return).
• Contributes to the generation, review, and approval of essential clinical study documents (protocol, ICF, CRF etc.).
• If applicable, arranges translation of documents, as well as translation quality check, as required.
• Ensures compilation of documents for submission to the competent authority(ies) and/or IRB/ethics committee(s) occur timely in collaboration with the regulatory department.
• If applicable, ensures that the Clinical Trial Application to the competent authority(ies) and the ethics committee(s) is completed.
• If applicable, ensure notification of the local competent authorities.
• Ensures that further submission and notification requirements are fulfilled (also for international studies).
• If applicable, organizes and participates in the investigator’s meeting, CRA training(s), and further meetings for study preparation.
• Generates and/or oversees generation of supportive documents, e.g.: Monitoring Manual/Plan, Investigator Manual, annotated CRF, forms/logs needed for the study, etc.
• Supports correspondence with ethics committee(s), competent authority(ies), local competent authority(ies), in case of questions and/or amendments, submission of additional documentation.
• Develops all required training materials and/or oversees development of all required training materials.
• Arranges for trainings of all study team members, as required.
• Supports set-up of site-related contracts.
• Reviews and approves of pre-study visit reports.
• Ensures creation of Trial Master File.

Major Duties During Project Execution Phase

• Generates, compiles, and ensures submission of documents related to amendments.
• Supports Regulatory Affairs department with the reporting requirements of competent authority(ies) and IRB/ethics committee(s).
• Keeps in contact with the sponsor for reporting and problem solving.
• Delegates work to assigned study team and monitors progress to ensure deliverables are being met.
• Provides accurate and timely status reports to the sponsor and Senior Management.
• Monitors advertising budgets.
• If required, participates in safety review and data monitoring committee meetings.
• Oversees study performance at sites, amongst others:

oTimely and high-quality reviews of monitoring visit reports.

oTakes care of proper handling and documentation of protocol deviations, as well as associated corrective actions.

oOversees queries, query trends, and resolution.

oOversees drug accountability.

oSupports CRA team.

oBe in direct contact with sites as necessary.

oBe vigilant for site/monitoring issues and take appropriate measures for resolution of issues. In case of significant site omissions, inform Senior Management.

• Oversees vendor study performance.
• Keeps oversight of supplies and logistics (medication, material, and laboratory samples).
• Oversees TMF/SMF and electronic working TMF maintenance.
• In case of audits, supports the auditor and coordinates audit preparation and follow-up.
• Coordinates budget control activities such as revising budget for potential changes and works with Finance to track project costs (pass-through costs and resource needs) against budget, identifies budget changes, and communicates budget changes to applicable parties.
• Arranges the support of site payments.
• Determines potential resource shortage or overage during the project and communicates the discrepancy with respective Senior Management for resolution.
• Proactively identifies potential changes in project timelines, budget, and scope and proposes contingency plans, if needed. Discusses major risks and issues with Senior Project Manager.

oEscalates significant or urgent issues and risks accordingly.

• Provides the study team with relevant new information about the study, updated documents, study status etc., and arranges for training as required.
• Organizes and coordinates meetings (regular study team meetings, discussions with the sponsor, and service providers, etc.).
• Ensures relevant meetings are documented in meeting minutes.

Major Duties During Project Closure Phase

• Supports end-of-trial declaration, synopsis of the clinical study report, and further documents, if required to Competent Authority(ies) and IRB/Ethics Committee(s).
• Supports Medical Writing department in the preparation of the Clinical Study Report.
• Finalizes study documentation (review of the close-out visit reports, finalize TMF, Clinical Study Report etc.).
• Organizes and participates in concluding meetings, e.g., safety review, final study team meeting, financial close-out.
• Ensures lessons learned are provided and/or transferred.
• Confirms final account and alignment with the budget.
• Conducts final check of the TMF and transfer to the sponsor.
• Additional duties as assigned and mutually agreed upon with management.

Knowledge/Education

Summary of Requirements

• Bachelor’s degree in Business Administration, Science, or related field, or equivalent experience.

Job Experience

• 5+ years of experience in the pharmaceutical and/or clinical research industry.
• 3+ years of experience in project management capacity or equivalent experience with demonstrated competence in managing project management activities.
• Demonstrated experience in managing low to moderate complexity trails.
• Experience with Good Clinical Practices, ICH, and local regulations pertaining to clinical trials.