Massachusetts Green Jobs

MassHire JobQuest Logo

Job Information

Thermo Fisher Scientific Senior Manager Clinical Affairs in Boston, Massachusetts

Position Summary:

The Senior Manager, Clinical Affairs is responsible for leading and managing the strategy, planning, and execution of clinical research and investigational affairs.

Essential Functions:

  • Develop global clinical affairs strategies, in collaboration with medical affairs, regulatory affairs, marketing, research & development, reimbursement, and outcomes planning, and obtain approvals by the most effective method possible

  • Develop and execute a Clinical Affairs Strategy to generate data for both marketing and regulatory purposes

  • Enroll and manage KOL / physician-clinician engagement and lead the management of all Clinical Affairs investments and required support

  • Support regulatory/clinical strategies as clinical affairs leader

  • Prepare and manage clinical affairs budget

  • Develop clinical study strategy and protocols for investigational devices and/or for new products being introduced to the marketplace

  • Oversee the management, planning, and execution of respective clinical studies

including:

  • Provide oversight of individual clinical trials to ensure full compliance with GCP and that safety concerns and/or adverse events are identified and appropriate responses to such concerns are executed

  • Travel to clinical sites for training and clinical trials monitoring purpose

  • Participate in investigator recruitment and selection activities and assist with clinical site contracting and budget negotiations

  • Serve as an interface to site coordinators, investigators and other field personnel regarding study devices and clinical protocols.

  • Develop training and other clinical study support materials for investigational or study devices and procedures

  • Train study centers, and field personnel on clinical protocol and investigational devices/products

  • Train site and field personnel on data collection methods to ensure collection of patient data that is accurate, complete and conforms to project data standards and protocol requirements

  • Interface with relevant internal and external stakeholders to ensure that clinical studies meet targeted enrollment and approval timelines

  • Oversee the execution of clinical studies in compliance with FDA, IRB and other applicable regulations and requirements, ICH guidelines, ISO standards, GCP requirements and in alignment with internal procedures, business goals and objectives

  • Responsible for market research, competitive analysis, and literature reviews in the field of transplantation clinical studies; remain current on market dynamics and competitive developments

  • Create and maintain relationships with internal and external partners

  • Responsible for data collection, analysis, and presentation to management

  • Responsible for preparing data for publication, white papers, presentations, etc.

  • Prepare and approves protocols for projects; reviews final study conducts documents such as study manuals, study plans, study tools, etc.

  • Develop staffing plans according to needs

  • Initiate investigator and coordinator meetings

  • Review and approve Clinical Risk-Benefit Analyses

Required Education and Experience:

  • BS/MS in either (Biomedical) Engineering, Science, or a related field.

  • 6-12 years’ experience in clinical/scientific medical devices/pharmaceutical clinical trials and research.

  • Experience managing projects and working with clinical professionals and cross-functional product development teams

  • Well versed in EU and FDA regulations and standards and GCP, ICH guidelines

  • Familiar with the laws, regulations, standards, and guidance governing the conduct of clinical studies

  • Highly organized and detail-oriented, with solid analytical skills

  • Ability to understand strategic goals and match the business needs of the company

  • Ability to independently manage and provide significant tactical leadership and guidance

  • Demonstrated ability to manage multiple, complex, and international projects

  • Prior experience in all aspects of FDA investigational studies

  • Excellent written and verbal communication skills and the ability to work with all levels of the Company

  • Familiarity with considerations and terminology of health care and/or medical device industry

  • Strategic thinking and analytical skills

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

DirectEmployers