Clinical Science and External Research (CSER) Manager

Kelly Science and Clinical FSP is currently seeking a Clinical Science and External Research (CSER) Manager for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Clinical Science and External Research (CSER) Manager

Location: Irvine, California (hybrid)

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
• 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:

• 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 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
  
  

Posted By: Karli Minor