Senior Manager Clinical Affairs

Job Title: Senior Manager Clinical Affairs – US

Job Number: 32871

Location: Remote, 

Job Description

This (Senior) Clinical Affairs Manager will assume responsibility for planning and execution of clinical trials. The Clinical Affairs Manager will be responsible for study timelines and budgets, preparation of study related materials, relationship management between study sites and CROs, supervision of study related activities, identification of project risks and contingency planning.

Responsibilities

• Independently manages clinical trials, including those conducted through Contract Research Organizations.
• Assumes overall responsibility for the development of protocols, clinical literature reviews, clinical trial. reports, annual reports, risk/benefit analyses, informed consent templates, and other clinical documents
• Develops study timelines, resource needs, and budgets and ensures accurate tracking and reporting of study metrics.
• Develops study plans including recruitment plan, monitoring plan, safety plan, other study-specific plans. Responsible for oversight of data management activities.
• Coordinates the design, format and content of study guides and subject instructions; participates in the development of Investigator Brochures.
• Serves as primary contact for the companies functional area representatives and vendors.
• Maintains regular communications with relevant departments such as R&D, Regulatory, Marketing, and others.
• Prepares and disseminates timely internal clinical trial updates.
• Responsible for the selection and day-to-day interaction with CROs and other external partners in the execution of assigned clinical trial(s). Monitors all outsourced activities including CROs, core laboratories and other external and internal partners.

This role may have personnel supervisory responsibilities.

Required Skills

• Bachelor's Degree in life sciences, health care or related discipline.
• Trial Manager experience 4+ in MedTech biotech, pharma, or a CRO.
• Working knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials.
• Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology.
• Systematic and efficient planning, decision making, prioritization, negotiation, and coordination skills.
• Excellent interpersonal, organizational, supervisory and project planning skills.
• Ability to effectively collaborate cross-functionally with R&D, Business, Regulatory, Legal, Quality, and other internal and external partners.
• Ability to work in multilingual/multicultural environment.
• Thorough knowledge and record of compliance with relevant regulations including but not limited to GCP, ICH E6, 21 CFR, and other relevant regulations and guidances governing conduct of industry-sponsored clinical studies.
• Ability and willingness to travel domestically and internationally; Valid driver’s license.