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TELA Bio · 1 day ago

Clinical Project Manager - Corporate or Remote

United States

Full-time

Remote

Mid, Senior Level

$100K/yr - $150K/yr

3+ years exp

TELA Bio is a company focused on clinical research and product development in the medical device sector. The Clinical Project Manager (CPM) is responsible for overseeing all aspects of clinical study design, execution, and close-out for assigned projects, ensuring compliance with regulatory requirements and successful completion of clinical affairs activities.

BiotechnologyLife SciencePharmaceutical

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

Qualification

Clinical project managementClinical operations experienceClinical research knowledgeMicrosoft Office SuiteETMFCTMSEDC systemsClinical Research CertificationProject management certificationMultitasking ability