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Trial Activation Approval Specialist I

extra holidays - extra parental leave

Remote:

Full Remote

Work from:

India

Offer summary

Qualifications:

Bachelor's degree in Life Sciences or related field, Proven experience in clinical trial management preferred, Outstanding attention to detail, Strong organizational skills.

Key responsabilities:

Prepare submissions to authorities and ethics committees
Drive timely activation of clinical trial sites

Thermo Fisher Scientific Biotech: Biology + Technology Large https://www.thermofisher.com

10001 Employees

HQ: Waltham

See more Thermo Fisher Scientific offers

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Are you ready to embark on a fulfilling career journey with Thermo Fisher Scientific Inc.? We are looking for a motivated and ambitious individual to join our PPD team as a Country Approval Specialist?. This outstanding opportunity allows you to contribute to world-class clinical trials, making a significant impact on global clinical research.

Responsibilities

Prepares and performs the submissions to competent authorities including the ethics committees.
Collect essential documents for the trial and sites assigned.
Reviews, prepares the IP greenlight packages and works with the study team for the site activation readiness.
Drive timely clinical trial site activations. Ensure all trial activations are flawless and comply strictly with regulatory standards.
Collaborate with cross-functional teams. Work closely with research sites, regulatory, and clinical operations teams to successfully implement trial activation plans.
Maintain comprehensive documentation. Keep meticulous records of all trial activation processes and approvals.
Identify and address potential issues: Determine any barriers to trial activation and collaborate with teams to resolve them promptly

Requirements

Educational background: Bachelor’s degree or equivalent experience in Life Sciences, Pharmacy, or a related field.
Experience: Proven experience in clinical trial management, study startup activities or a related research role is preferred.
Skills: Outstanding attention to detail, strong organizational skills, and the ability to work collaboratively in a fast-paced, dynamic environment, understanding of clinical trial requirements, regulation and GCP guidelines. .
Communication: Excellent verbal and written communication skills to effectively interact with diverse teams, collaborators, and customers.
Technical proficiency: Familiarity with clinical trial management systems and regulatory requirements.

Join us on our mission to enable our customers to make the world healthier, cleaner, and safer. Your expertise and dedication will contribute to our continued success and innovation in the scientific community.