Clinical Project Manager - Corporate or Remote

Tela Bio Inc•Malvern, PA

1d•Remote

About The Position

Position Description Position Title: Clinical Project Manager - Corporate Office or Remote Position Overview: The Clinical Project Manager (CPM) is responsible for all aspects of clinical study design, execution, and close-out for assigned projects. This includes pre-and post-market studies, prospective and retrospective data collection, investigator-initiated studies, grants and registries. The CPM also manages clinical activities related to global registrations including Clinical Evaluation Reports (CERs) and Post Market Clinical Follow-up (PMCF) Plans and Reports. The CPM is accountable for successful completion of TELA Bio Clinical Affairs activities by meeting company and regulatory requirements according to time, quality and budget constraints. The CPM must have a thorough knowledge of clinical research concepts, FDA and EU regulations, and ICH and ISO Guidelines regarding clinical research and data management.

Requirements

Bachelor’s degree in Nursing, Life Sciences (biology, chemistry, biochemistry, physics, etc.) or Engineering discipline.
3-5 years of clinical operations experience with at least two years of clinical project management experience.
Proficient in Microsoft Office Suite and working knowledge of eTMF, CTMS, and EDC systems.

Nice To Haves

Experience at a sponsor or CRO within Medical Devices is strongly preferred.
Experience developing and writing clinical study protocols and reports is a plus.
Clinical Research Certification (SOCRA or ACRP) and/or project management certification (PMP) is desired.

Responsibilities

Proactively manage all operational aspects of clinical studies and/or data collection activities including trial timeline, budget, resources, sites and vendors (CROs, statistician, etc.).
Ensure that data collection and reporting activities are in compliance with all legal and regulatory requirements (HIPAA compliance, IRB approval, informed consent, etc.)
Lead study startup process including vendor agreements, site selection, clinical trial agreements and budgets, and set-up of the trial master file (TMF).
Develop and actively manage clinical project plans to ensure successful completion of all project deliverables in accordance with GCP, company SOPs, and applicable regulatory requirements.
Develop and maintain all internal TELA Bio clinical trial related SOPs including site selection, site initiation, adverse event management, monitoring visits, etc.
Collaborate with Quality Assurance to ensure timely notification and processing of device related adverse events.
Evaluate study performance to plan and develop corrective actions. Identify and communicate study risks along with recommended mitigation strategies.
Develop and manage study monitoring plans, review and approve site monitoring reports, and ensure follow-up and resolution of all site issues in a timely manner.
Provide regular updates on study timelines, budgets, and risk mitigation activities.
Serve as Clinical representative on new product development teams, ensuring trial needs (adequate study device production, site setup, etc.) are met in the development process.
Manage the Clinical Evaluation and Post Market Clinical Follow-up processes to ensure compliance with EU and UK regulations for CEPs, CERs, PMCF plans, and PMCF reports.