Clinical Science and External Research (CSER) Manager

Summary

The CSER Manager will lead the end-to-end management and oversight of the collaborative study program. In collaboration with cross-functional teams and research investigators, the CSER manager will generate clinically relevant evidence for the company's innovative pipeline that impact patient lives.

Responsibilities

• Handles assigned study programs (post market and premarket collaborative studies)
• Manages the external research program activities ensuring high adherence to SOPs, ICH-GCPs
• Responsible for new study proposal review, budget and resource review, ensures timely decision making and execution of approved studies including while working with external stakeholders
• Utilizes program data and metrics to conduct regular reviews of the program and provides updates to team leadership
• Supports evidence generation and dissemination strategy through external research program, including alignment of publication plan and identifies gaps
• Drives publication development with investigators and internally cross functionally with scientific affairs. Provides critical scientific input to publications
• Develops positive relationship with external researchers and diverse cross-functional teams including Medical Affairs, Biostatistics, clinical research, Compliance, Legal and regulatory to drive timely program execution and success
• Stays on top of current scientific data, leads literature reviews, participates in monthly literature review and shares key insights with global teams
• Oversees budget associated with assigned research projects
• Works in close collaboration with team of study coordinators and research scientists

Position Duties & Responsibilities

• Clinical trial management experience is required.
• Experience with regulatory trials (pre-market) is an asset
• Strong project management skills with the ability to balance multiple projects
• Strong scientific capabilities and research background, can think creatively to bring forth new insights and innovative ideas to grow external research collaborations leading to impactful publications and meeting evidence needs.
• Able to influence others along with strong written and oral communication skills
• Strategic mentality and critical analytical skill
• Shown understanding of biostatistical methods
• Successful experience in publication planning and development
• Knowledge of Good Clinical Practices and ICMJE standard
• Leadership in evidence generation strategy

Requirements

• A minimum of a Bachelor’s or Master's Degree with at least 8 years of clinical, medical affairs or related technical experience.
• PhD/MD/ PharmD with industry/academic research experience preferred.
• A minimum of 1-2 year people management related experience is desirable for this role.
• A Life Science, Physical Science, Nursing, or Biological Science degree preferred.
• Medical device experience, especially in cardiovascular and/or electrophysiology therapeutic experience highly preferred
• Pre- or Post-market study design and management experience
• Experience with medical writing and systematic literature review desired