Project Manager, eTMF job in Bethesda at Technical Resources International
Technical Resources International

Bethesda, Maryland

This job has expired.


Responsibilities:

  • Assists with plans and management of day-to-day operational aspects of one or more assigned programs/projects or tasks, including the following, as required: planning/timelines, budgeting/resourcing, and vendor management/interfacing. Identifies and proactively works to remove obstacles, mitigate risks, and escalates issues; both internally and to the client [Contracting Officer's Representative (COR), or designee(s)], as needed
  • Act as the main point-of-contact for study eTMFs
  • Serve as the subject matter expert on domestic/international documentation requirements
  • Maintain and manage overall eTMF operations including metadata specifications, filing, and quality control (QC) of all study documents from set-up to archival
  • Ensure documentation flow is within projected timelines and determine course of action to prevent and remediate delays
  • Maintain study specified document lists at the study, country, and site levels by collaborating with all relevant functional lines such as data management, regulatory, etc. to ensure documentation is in place for the study and all versions/instances are filed in a timely fashion
  • Create and maintain study-specific tracking tools and project files, as needed
  • Manage eTMF structure and documentation during all audits and regulatory inspections
  • Participate in audits and/or inspections of clinical operations and the eTMF
  • Manage clinical documents and ensure documents are current and inspection ready at all times.
  • Help identify, create, and establish study tools for the department
  • Perform duties within established SOPs and in accordance with Good Clinical Practice (GCP).
  • Perform verification and quality control of essential regulatory documents
  • Manage the eTMF systems and ensure TMF Inspection Readiness is current and inspection ready at all times
  • Ensure that the eTMF is complete, contemporaneous, and quality ensured
  • Manage eTMF projects and perform a risk-based review of eTMF activities being performed by clinical operations and external vendors
  • Manage eTMF projects, assist with overall change management, and build collaborative relationships with cross-functional teams.
  • Provide support to clinical operations during eTMF implementation, audits, and/or regulatory inspections.
  • Ensure functional compliance with eTMF SOPs, relevant eTMF process-supporting guidance, and applicable global regulations
  • Perform risk-based quality content reviews and monitor internal/external KPIs
  • Represent eTMF operations at study team meetings, participate in collaborative efforts and play an important cross-functional role in eTMF document retrieval and management
  • Ensure documents which fail eTMF quality content and/or eTMF inspection readiness review are effectively remediated by internal/external representatives
  • Monitor and identify study specific eTMF trends and escalate concerns
  • Coordinate the long-term storage archival of original documents and maintain document integrity, per mandatory retention policies
  • Assist in developing TMF/eTMF related SOPs, forms, and plans, to ensure compliance with ICH E6(R2).
  • Ensure clinical privacy and security standards are met and adhered to
  • Lead eTMF educational workshops and trainings
  • Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance
  • Ability to effectively communicate with study team members and work closely to address challenges
  • Ability to manage multiple timelines
  • Ability to maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities
  • Display excellent organizational skills and exhibit professionalism and integrity
  • Strong verbal and written communication skills.
  • Support and comply with the company's Quality Management System policies and procedures.

Requirements:
  • Bachelor's Degree in related field with two additional years of experience in a pharmaceutical, biotechnology, or related environment in roles focused on clinical trial documentation
  • 5+ years of experience in a pharmaceutical, biotechnology, or related environment in roles focused on clinical trial documentation
  • Excellent leadership skills for a diverse team with specialized expertise
  • Extensive knowledge and application of Good Clinical Practice, and Good Documentation Practices to include domestic and global regulatory requirements and guidance
  • Expert knowledge of clinical study files documents, eTMF Reference Model, clinical trial activities, and terminology.
  • Demonstrated proficiency in eTMF, including in study start-up, maintenance, close-out, and performing quality control and comprehensive completeness reviews
  • Demonstrated ability to navigate EDC systems and review data to meet project objectives
  • Experience with Veeva Vault eTMF software

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