Job Description Summary
This role provides administrative support to the Study Managers/Study Directors as they oversee clinical studies. The Senior CTA will assist with Vendor oversight, tracking and all other administrative duties relating to the conduct of the studies. This role will also support all clinical archive systems (legacy, paper, electronic) and is responsible for maintenance and review of Trial Master File (TMF)/electronic TMF documentation. In addition, this role supports all ongoing clinical trials outsourced to external Vendors by overseeing TMF records and reviewing GEHC study documentation to ensure it is managed in accordance with ICH-GCP, GE SOPs, Vendor SOPs and all other applicable regulations. Senior CTA will lead TMF oversight activities and coordinate or mentor less experienced CTAs as required.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Roles and Responsibilities
- Management and Maintenance of TMF and reconciliation with Investigator Site File in collaboration with the vendor.
- Work with vendor to execute a TMF plan
- Perform QC on submitted TMF documents from vendor and internal staff and feedback appropriately to ensure documents are filed correctly in accordance with the TMF plan.
- Arrange and lead regular meetings with vendor staff related to TMF management to ensure the vendor maintains high quality documents in accordance with the TMF plan.
- Review Vendor SOPs to ensure document management process is adequate and compliant as required.
- Lead continual review of eTMF and by working with Vendor as necessary
- Ensure that the TMF/eTMF archive is maintained to ensure compliance with relevant regulations.
- Manage and control the distribution of Investigator Brochures per GE SOPs as required.
- May be given responsibility of designated Archivist position (to be appointed separately)
- Work effectively with internal cross functional team
- Perform management of non-IMP Clinical Supplies and Equipment for Study Centres where applicable
- Oversee organization of Investigator Meetings and participate as required
- Participate in Internal/External Study Team Meetings and manage agenda and minutes
- Collate tracking information provided by Vendor(s) for internal status reporting
- Assist Study Manager/Study Director with processing and tracking of Invoices
- Assist Study Manager/Study Director with maintenance of Study Management Plan(s) Provide support to Study Manager/Study Director as required with all other ad hoc requests
- Support internal audits and regulatory inspections as needed including providing requested regulatory documents and all other inspection activities as required.
- Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type.
- Complete all planned Quality and Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required.
Personal specification
Qualifications
Experience working on Clinical Trials within the pharmaceutical, biotech or healthcare industry and working with electronic clinical trial management systems but less experience will be considered
Skills/Attributes
- Ability to work on multiple projects and prioritise effectively
- Prior knowledge of the clinical trial process
- Ability to work across functions and within teams
- Strong written and verbal communication skills
- Willing to travel as required
- Well organised with good attention to detail
- Diplomatic and cooperative team member
Inclusion and Diversity
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Additional Information
**Relocation Assistance Provided: **No