Clinical Research Manager

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. OVERALL 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 Contributes to protocol development of assigned studies 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: Functional and Technical Competencies: 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 EDUCATION & EXPERIENCE 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 years 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 #J-18808-Ljbffr