- Ogłoszenie wygasło 13 dni temu
- Umowa o pracę
- Pełny etat
- Specjalista (Mid / Regular)
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.
- 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
- 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
- Generous benefit package
- Professional development opportunities
- Individual approach