Clinical Study/Project Manager III

Job Description

Primary Function of Position:

This position reports to the Manager, Clinical Affairs and requires a candidate with extensive experience helping with evidence generation strategy and execution of clinical studies.

The Clinical Study Manager-3 (CSM III) role will develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, this role will be responsible for working with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision. The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports or assist in the development of clinical publications.

During trial execution, the CSM will drive the progress of the trial during site selection, site start-up and through enrollment and follow-up. The CSM will clearly provide guidance to the monitors about monitoring needs and oversee compliance work on the study. The CSM will also take a leadership role in external communication with investigators and study teams.

The ideal candidate will have experience previously managing premarket studies in the United States and utilizing resources to research and scope research topics and to provide recommendations on clinical trial strategy. The candidate is also expected to have experience reviewing, interpreting and summarizing clinical literature.

Roles & Responsibilities:

• Responsible for leading assigned clinical research activities
• Partner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives
• Responsible for the planning and execution of the clinical studies including site selection, assessment of potential patient recruitment and projections, creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements, study reports), organizing IRB/EC submissions with follow thorough to ensure successful progress
• Responsible for autonomously conducting clinical studies on schedule and within budget while ensuring high quality and compliance
• Liaise with external vendors and sites to negotiate contracts and budgets in partnership with the legal team and management
• Track study progress and provide regular status reports
• Work closely with Biostatisticians on data analysis, interpretation and synthesis, in order to develop clinical study reports and /or help development of scientific publications
• Organize and run study meetings and other study activities as assigned
• Mentor junior clinical study manager(s); provide guidance to CRAs and CTAs on monitoring and other study needs
• Follow corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US and OUS guidelines) and proactively manage studies, following such guidelines and requirements
• Conduct literature searches and familiarize with literature to stay informed and abreast of relevant scientific/clinical knowledge and/or to establish evidence gaps
• Critically appraise scientific literature and write clinical summaries to assist research and the development of clinical strategies and clinical investigational protocols.
• Review and revise Clinical Operations Standard Operating Procedures (SOPs) to assist Clinical Affairs leadership with continuous process improvement initiatives
• For post-market research, partner with commercial groups (i.e. marketing) to recognize market trends and utilize information to help with business goals through Clinical Affairs activities
• For post-market research, provide scientific expertise to the Health Economics and Outcomes Research department for development of outcomes research insights (including identification of appropriate diagnosis or reimbursement codes, selection of clinical outcomes for procedures of interest)
• Work with clinical investigators to prepare manuscripts, abstracts, slide presentations, and poster presentations for scientific meetings and publications in partnership with management
• Assist with Regulatory submission and approval of pre-market clinical studies and 510k(s), responsible for addressing regulatory body questions on clinical study design and results (e.g., protocol, ICF, eCRF, clinical study reports)

Qualifications

Skills, Experience, Education, & Training:

• Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 2-3 years of experience in clinical research, or Bachelor’s degree in a scientific/bioengineering field with a minimum of 5 years of experience in clinical research is preferred
• Previous experience implementing, aiding and managing medical device trials
• Significant knowledge of clinical and/or outcomes research study design
• Proven experience in protocol and ICF development, writing clinical section(s) for regulatory submission
• Solid experience in conducting literature searches, reviews and appraisal of the scientific data
• Excellent ability to interact with physicians and other professionals inside and outside the company
• Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
• At ease in a hospital environment, experience working with nurses and surgeons preferred
• Experience negotiating clinical research contracts and budgets
• Knowledge of statistics, statistical methods, and design of experiment is highly preferred
• Must be able to work effectively on cross-functional teams
• Must be able to travel 25% on average
• Must be able to manage multiple projects and/or align business needs effectively
• Exceptional communication, presentation and relational skills with high attention to detail and organization
• Ability to learn quickly, adjust to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects (“Self-starter attitude”)
• Ability to steer project team consisting of CRAs and CTAs and support management with relevant study updates
• Exhibits excellent work ethic to help meet high priority timelines or multiple projects when necessary with a problem-solving mindset