Manager, Clinical Affairs - Military veterans preferred

Position Title:  Manager, Clinical Affairs

 Position Overview:

The Manager, Clinical Affairs has management oversight for the execution of post-market studies, prospective and retrospective data collection, investigator- initiated studies, grants, and registries. This role is accountable for successful completion of all project deliverables in accordance with company SOPs, GCP, and any applicable regulations.

The Manager, Clinical Affairs will drive the execution and implementation of systems, practices, and processes to ensure efficient and effective clinical operations including protocol development, trial management, data analysis, final study report and publication.  This role directly manages internal clinical staff, Contract Research Organizations (CROs), and external consultants, with responsibility for resource allocation, budgeting, expense allocation, and project prioritization.

 Essential Duties and Responsibilities: 

• Manage a proficient clinical research operations team using internal and external resources (CROs, consultants, etc.).
• Oversee the operational aspects of clinical studies and data collection activities, ensuring timely execution of clinical activities including protocol development, trial timeline, budget, resources, sites and vendors (CROs, statistician, etc.), maintaining alignment with protocol requirements, internal procedures, applicable regulations, and good clinical practices.
• Responsible for overseeing post-market trial data analysis and reviewing and approving clinical study reports, ensuring data collection and reporting activities, compliant with all legal and regulatory requirements (HIPAA compliance, IRB approval, informed consent, etc.).
• Monitor and provide regular updates on study timelines, budgets, and risk mitigation activities.
• Analyze and report on trial performance to plan, ensuring swift issue resolution and development of corrective actions where necessary.
• Ensure proper supervision and training for all clinical study staff, CRO resources and field CRAs.
• 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.
• Participate in cross-functional review of externally facing documents (e.g. clinical study reports, manuscripts, conference abstracts, marketing materials, regulatory submissions) to ensure accuracy and relevancy of presented data
• Remain current with relevant medical literature, clinical guidelines, societal and international committees, and industry trends.
• Collaborate cross-functionally with regulatory, legal, compliance and other departments as required.
• Attend and participate in regional, national, and international scientific and clinical meetings.
• Develop and foster relationships with key clinical customers (e.g., physicians, nurses, administrators, research staff).

 Education and Experience:

• Bachelor’s degree in Life Sciences or related field
• Advanced degree preferred

 Required Knowledge, Skills and Abilities: 

• Minimum of 5+ years of experience in clinical operations with at least 3 of those years in clinical study management; Medical Devices is preferred.
•  Minimum of 2+ years of direct people management experience
• Demonstrated ability to provide coaching and feedback, including successful track record of hiring, professional staff development, and performance management
• Demonstrated ability to successfully design post-market clinical studies to support regulatory filings and sales/marketing data requirements; experience in medical devices preferred.
• Solid understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP, ISO 14155, CFR 820, 
• EU MDD/MDR, UKCA); ability to work within the constraints of a regulated industry while achieving objectives
• Excellent interpersonal relationship skills including collaborating, negotiating, and influencing to drive achievement of objectives.
• Strong communication (oral and written) skills including publications, regulatory documents, and presentations; ability to communicate in small and large settings and with all organizational levels, regulatory agencies, and physicians.
• Ability to thrive in a fast paced, dynamic, and constantly changing work environment with competing priorities
• “Hands-on”, “roll-up-the-sleeves” leader who understands the need for involvement in a small company environment while recognizing when to delegate and seek results from the team.
• Proficient with MS Office Suite and clinical systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file), and EDC (electronic data capture)

 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, home office or clinical environment.  The noise level in the work environment is quiet to moderate.  

 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 the 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