What are the responsibilities and job description for the Manager, External Research position at Kelly Science, Engineering, Technology & Telecom?
Manager, External Research
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 crossfunctionally 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
Salary : $150,000 - $175,000