Trial Activation Approval Specialist I at Thermo Fisher Scientific
Company: Thermo Fisher Scientific
Position: Trial Activation Approval Specialist I
Location: Remote (India)
Experience Required: 2-5 years
Educational Requirements: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, or Life Sciences degree
Application Mode: Online
About Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in scientific research, services, and innovative solutions. With a strong commitment to advancing healthcare, the company plays a significant role in addressing health challenges worldwide. Thermo Fisher’s PPD clinical research team ensures innovative therapies and drugs reach patients, contributing to global health solutions by streamlining the process for new drug approvals.
The PPD team at Thermo Fisher supports a wide array of clinical trials by assisting with comprehensive clinical research needs. As part of this commitment, the Trial Activation Approval Specialist I role is integral to initiating clinical studies, ensuring regulatory compliance, and enabling efficient trial activations. Trial Activation Approval Specialist I at Thermo Fisher Scientific
Role Overview
As a Trial Activation Approval Specialist I, you’ll work with a dynamic team to manage and conduct regulatory submissions, site activations, and documentation processes that support the startup of clinical trials. This position emphasizes collaboration, compliance, and adherence to Good Clinical Practice (GCP) guidelines, where you’ll ensure that all regulatory requirements are met to facilitate site readiness for trials.
Reporting Structure:
This role reports to the Manager of Clinical Operations or a designated team leader within the PPD division. Collaboration will be frequent with cross-functional teams including clinical research sites, regulatory agencies, and various internal departments to drive trial site activations efficiently. Trial Activation Approval Specialist I at Thermo Fisher Scientific
Key Responsibilities
| Responsibility Area | Description |
|---|---|
| Regulatory Submissions | Prepare and submit documentation to competent authorities and ethics committees to meet trial requirements. |
| Document Collection | Gather essential trial and site documents needed for submission and trial initiation. |
| Site Activation Readiness | Coordinate with study teams to prepare IP greenlight packages, ensuring sites meet readiness criteria. |
| Site Activations | Actively drive the activation of clinical trial sites while ensuring compliance with regulatory standards. |
| Cross-functional Collaboration | Work closely with clinical operations, research sites, and regulatory bodies to support smooth trial setup. |
| Documentation Management | Maintain accurate and comprehensive records of activation processes and regulatory approvals. |
| Issue Identification and Resolution | Identify potential barriers to site activation and collaborate with teams to resolve issues efficiently. |
These responsibilities are essential to the initiation and maintenance of high-quality clinical studies, ensuring that trials begin on schedule and maintain regulatory compliance throughout their duration. Trial Activation Approval Specialist I at Thermo Fisher Scientific
Skills and Abilities
Thermo Fisher seeks a detail-oriented and proactive individual capable of thriving in a collaborative and fast-paced environment. Key skills include:
- Attention to Detail: Ensures precision in document handling, submissions, and regulatory requirements.
- Organization and Multitasking: Manages multiple site activations and regulatory submissions simultaneously.
- Regulatory Knowledge: Strong understanding of GCP guidelines, trial regulations, and clinical study requirements.
- Technical Proficiency: Familiarity with clinical trial management systems and a sound knowledge of regulatory documentation processes.
- Communication Skills: Excellent verbal and written communication skills to effectively interact with team members, research sites, and regulatory bodies.
These competencies allow the Trial Activation Approval Specialist I to effectively support the complex documentation, regulatory, and activation processes involved in clinical trials. Trial Activation Approval Specialist I at Thermo Fisher Scientific
Qualifications
To be considered for this position, candidates must meet the following qualifications:
- Educational Requirements: Bachelor’s degree or equivalent in Life Sciences, Pharmacy, or a related field (B.Pharm, M.Pharm, Pharm.D, MSc, or BSc).
- Experience: 2-5 years in clinical trial management, study startup, or a related field, with proven experience in clinical trial site activations, regulatory submissions, or clinical study management.
Personal Attributes
Thermo Fisher is looking for a proactive and adaptable individual who can navigate the complexities of clinical trial startups with resilience and initiative. Ideal candidates exhibit:
- Collaborative Spirit: Comfortable working in a team-based, fast-paced environment, where cross-functional collaboration is crucial.
- Problem-Solving Abilities: Resourceful and proactive in addressing issues that may arise during site activation and trial setup.
- Adaptability: Capable of handling changing regulations and project demands with flexibility and a positive attitude.
- Commitment to Compliance: Demonstrates a strong commitment to regulatory standards and high-quality documentation management.
Growth Opportunities
Thermo Fisher offers substantial growth opportunities within the organization, especially for those interested in clinical trial operations and regulatory roles. By joining the PPD clinical research team, you will have the chance to work on significant projects with a global impact on health. With an emphasis on professional development, Thermo Fisher provides training programs and growth opportunities to support your career advancement. Trial Activation Approval Specialist I at Thermo Fisher Scientific
Why Join Thermo Fisher Scientific?
Thermo Fisher Scientific is dedicated to fostering a work culture that values flexibility, work-life balance, and professional growth. By joining Thermo Fisher, you’ll work in an environment where your contributions directly impact patient lives. The company is also committed to continuous learning, offering opportunities to develop and refine skills in clinical research and trial management.
Benefits: Thermo Fisher provides a comprehensive benefits package, including competitive compensation, health insurance, retirement plans, and paid time off.
How to Apply
Interested candidates can apply through Thermo Fisher Scientific’s online application portal. Please ensure your resume highlights your experience in clinical trial management, study startup, regulatory submissions, and relevant educational background.
Join Thermo Fisher Scientific and contribute to advancing global health by playing a key role in clinical trials that bring innovative therapies to patients worldwide.
More Jobs
Sarkari Jobs