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Clinical Research Executive
hace 3 meses
At Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale. Join our team in realizing our Mission - empowering our clients to create a healthier, cleaner, and safer world. We equip our teams with the necessary resources to achieve personal career aspirations while advancing science through research, development, and the delivery of transformative therapies. With clinical trials conducted in over 100 countries and the continuous evolution of innovative frameworks for clinical research through our PPD clinical research portfolio, our efforts encompass laboratory, digital, and decentralized clinical trial services. Your commitment to delivering quality and precision will enhance health outcomes that individuals and communities rely on – both now and in the future.
Explore Meaningful Contributions:
This role offers strategic leadership and operational oversight for the clinical and medical dimensions of all stages of the clinical drug development lifecycle. The incumbent is accountable for the formulation, development, and execution of Clinical Development Plans (CDPs), clinical trials, and protocols in alignment with applicable GCP regulations. This individual leads and contributes to the evaluation of study outcomes, assessing the degree to which the study(ies) have met clinical and regulatory objectives, and documenting the results of the studies.
This role may serve as a clinical and medical representative in discussions with external stakeholders (collaborators, Key Opinion Leaders (KOLs), investigators, regulatory bodies, etc.), partners (vendors, consultants, etc.), and other external audiences as required.
We currently have client-dedicated and internal PPD positions available in the field of Psychiatry / Neurology.
A Day in the Role:
- Provide medical expertise and leadership for clinical studies
- Oversee medical monitoring of clinical trials
- Establish and endorse scientific methodologies that underpin the design and execution of clinical protocols
- Ensure the safety of study participants
- Regularly assess adverse events, laboratory results, and other clinical data, ensuring timely reporting
- Collaborate with the study executive and independent safety committee as necessary
- Represent clinical research through participation in trial teams
- Contribute to, review, and approve study protocols, amendments, study manuals, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), and other clinical documents as required for the execution of clinical trials
- Interpret, summarize, and document clinical data for regulatory submissions (INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as necessary
- Collaborate with leading academic medical institutions
- Recruit, guide, and inspire clinical investigators
- Ensure compliance with all relevant SOPs and GCPs
- Engage in long-term strategic planning
Qualifications:
- MD degree with a specialization in Psychiatry/Neurology is essential
- Experience in drug development within the Psychiatry/Neurology domain
- Desirable: Experience in therapeutic areas such as Monoclonal Antibodies and/or Translational Medicine
Skills and Competencies:
- Demonstrated commitment to proactive problem-solving
- Exceptional leadership capabilities
- Ability to provide multiple examples of developing and implementing scientific and clinical principles for clinical studies and trial protocols
- Proven expertise in clinical trial design, execution, and data interpretation
- Prior experience with regulatory submissions
- Excellent written and verbal communication skills
- Willingness to travel
Our Mission is to empower our clients to create a healthier, cleaner, and safer world. As part of a team of over 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working collaboratively to accelerate research, address complex scientific challenges, drive technological advancements, and support patients in need.
