Tela Bio Inc

Compensation

Full Description

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. Essential Duties & 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. Required Education and Experience: * Bachelor’s degree in Nursing, Life Sciences (biology, chemistry, biochemistry, physics, etc.) or Engineering discipline.   Required Knowledge, Skills and Abilites: * 3-5 years of clinical operations experience with at least two years of clinical project management experience. * Experience at a sponsor or CRO within Medical Devices is strongly preferred. * Proficient in Microsoft Office Suite and working knowledge of eTMF, CTMS, and EDC systems. * 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. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Must be able to: * ·      Ability to carry and lift product inventory of up to 10 lbs. * Must have demonstrated ability to multitask in high pressure, changing conditions.   Working Conditions: This position works in a home office, hospital, HCP office or clinical environment.  The noise level in the work environment is quiet to moderate.  Travel, as required, up to 30% Primary Location and Travel:  * Ability to travel up to 30%.   We anticipate that on an ongoing basis this role will be a office-based position although incumbent will need to participate in face to face Corporate meetings as needed.   Disclaimers:  This is a representative description of the job and is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice. TELA Bio, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law. For more information, please check out our website: www.telabio.com [http://www.telabio.com]