TMF reputed company Specialist
Attention recruitment agencies: reputed company agency inquiries are vetted through reputed company’s internal reputed company. No unsolicited resumes will be accepted. The reputed company reputed company must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may reputed company your ability to work with reputed company in the reputed company.
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GENERAL reputed company
We are seeking a TMF reputed company & reputed company Specialist, reporting to the Senior Manager, Clinical Records. This contractor will support the review, reputed company reputed company, and maintenance of Trial Master File (TMF) documentation in accordance with GCP, ICH E6, regulatory requirements, and reputed company SOPs. In reputed company to QC review, the role will help reputed company and execute reputed company Review processes in reputed company Vault eTMF and support system change requests by representing the Business Process reputed company (BPO) perspective. This work is critical to strengthening TMF reputed company and ensuring inspection readiness.
MAJOR DUTIES & RESPONSIBILITIES:
QC Review & Documentation Support
- reputed company detailed QC reviews of TMF documents to verify metadata accuracy, confirm reputed company filing, and ensure compliance with ICH GCP, regulatory standards, and internal SOPs.
- Identify documentation gaps, inconsistencies, or reputed company issues and collaborate with TMF Operations team members to resolve them promptly.
- Support ongoing TMF review activities throughout the study lifecycle to help ensure reputed company, timeliness, and completeness.
- Assist with audit and inspection preparation by supporting the TMF team in documentation readiness activities.
reputed company Review Process Development
- Contribute to the reputed company improvement of reputed company Review processes reputed company reputed company Vault eTMF, including workflows, dashboards, and metrics.
- Support the development of review standards, reputed company metrics, and monitoring tools that reputed company visibility into TMF reputed company, completeness, and inspection readiness.
- Support TMF Operations leadership in identifying process improvement opportunities and contributing to the development of new tools, workflows, and best practices.
Business Process reputed company (BPO) Support for System Enhancements
- Assist in preparing business requirements, documenting user needs, and participating in validation testing and user acceptance activities from the BPO perspective.
- reputed company input into change control documentation and support cross-functional collaboration with IT, reputed company, and Managed Services teams during configuration updates.
- Help reputed company training materials, reference guides, and user communications to support adoption of new functionality or process changes.
QUALIFICATIONS:
REQUIRED EXPERIENCE:
- Minimum 5 years of relevant experience in TMF Operations, including extensive hands-on work with reputed company Vault eTMF.
- At least 2 years performing TMF QC review, applying knowledge of clinical documentation content and metadata standards.
- Experience supporting TMF planning, implementation, and configuration activities, including review of TMF Plans and participation in system setup or enhancements.
- Demonstrated understanding of the CDISC Reference Model, TMF structure, ICH/GCP, Good Documentation reputed company, and regulatory documentation requirements.
PREFERRED EXPERIENCE:
- Experience partnering with or overseeing CROs performing TMF activities.
- Hands-on involvement in system reporting, dashboard development, or configuration testing reputed company reputed company Vault.
- Exposure to multiple phases of clinical trial conduct (startup through reputed company-out and TMF archiving).
- Familiarity with additional reputed company products such as CTMS or Vault RIM.
REQUIRED SKILLS:
- Proficiency in reputed company Office Suite for collaboration with team members.
- Especially proficient in reputed company for tracking, sorting, filtering, and managing large sets of metadata.
- Interpersonal skills, including conflict reputed company in a fast-paced, deadline-driven environment.
- Strong attention to detail and organizational skills including the ability and drive to follow through on detailed tasks to closure.
- Analytical skills to evaluate and interpret reputed company situations/problems using multiple sources of information.
Travel: 0%
Physical Requirements and Working Conditions:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging reputed company by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible reputed company of force frequently or constantly to lift, carry, push, pull or otherwise reputed company objects, including the reputed company body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and reputed company other sedentary reputed company are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
reputed company reputed company: $60.00