Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Analgesia, Neuroscience, Oncology, Dermatology, Pediatrics, and Rare Diseases.
We’re looking for a talented and energetic TMF Lead to join our team! This is a very exciting opportunity to join a dynamic and innovative team and grow with a forward-thinking organization that is changing to course of medicine.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
As the TMF Lead, you’ll have the opportunity to lead and perform essential document management and electronic and paper Trial Master File records management activities. You’ll ensure these records are managed according to study, Company and Sponsor timelines while consistently meeting quality standards. You’ll be able to work closely with Project Teams and even clients on compliance to essential document management and/or TMF SOPs and TMF Plans. In this role, you’ll need to takes initiative to identify and address key performance indicators and quality issues impacting the successful management of high quality TMFs.
What you’ll be doing:
- Act as primary point of contact for project teams, Sponsors, auditors and other parties on assigned studies/programs; participate in client and internal calls as a functional lead and provides status updates; participate in business development presentations and system demonstrations, study KOMs and other targeted project team meetings globally
- Supervise department team on assigned studies/programs and ensure utilization targets and performance metrics are met and scope of work is performed according to budgets and timelines for assigned studies/programs; oversee Project Team compliance to essential document management requirements, TMF SOPs and TMF Plans for assigned studies/programs and supervised staff; provide mentoring and training of new hires, project teams and external staff; assist management with candidate review, interviews, hiring recommendations, as well as on-boarding and training of department staff globally
- Ensures that any out of scope activities are identified, reported to department management, itemized with project leadership and appropriately budgeted in change orders for assigned studies/programs
- Lead or assist management with department continuous improvement activities globally
- Supervise the security, environment and access control of Secure File Room (SFR) facilities located in their local office or region
- Perform all departmental budgeted activities for assigned studies/programs
- Identify, report and resolve quality and efficiency concerns with records management work practices
- Participate in the development of departmental SOPs, Working Guidelines, Associated Documents, training materials, etc.
- Write TMF Plans, TMF indexes, transition plans, etc. for assigned studies/programs
- Conduct or supervise quality review of TMFs in accordance with SOPs for assigned General, Country and/or Site level files
- Liaise with project teams to ensure the expected level of essential document quality is maintained throughout the study
- Assist Management with review of departmental budgets, timesheet review and productivity/quality metric collection, analysis and reporting for department staff on assigned studies/programs
- Conduct live, web-based and/or recorded process and/or system training for company staff, Sponsors and/or third parties
You’ll need this to be considered:
- Undergraduate degree or international equivalent with a concentration in records and information management, library science, clinical, science or health related field along with 6+ years of clinical trials essential document management and/or records management experience, including demonstrated results as a Senior Records Specialist or equivalent in a clinical trials essential document management and/or records management setting.
- Significant experience using computerized clinical trials records management technologies is required.
- Knowledge of global/national health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the clinical trial essential document management and records management activities will be performed.
- Significant knowledge of ICH-GCP, ISO14155 and global regulations pertaining to essential document management and Trial Master File management is required.
- Advanced knowledge of web-based communication tools for conferences and any other IT systems required for the job is required.
- Excellent team player, collaborative and able to work within an effective team
- Proven ability to multitask and work effectively in a fast-paced CRO environment with changing priorities
- Attention to accuracy, consistency and detail oriented; excellent organizational and time-management skills, able prioritize work to meet deadlines
- Strong verbal and written communication and negotiation skills with the ability to read, write and speak fluent English
- Accountable, dependable and strong commitment; maintains a positive, professional, results orientated work environment