Address
Form of workThe Associate Director of Clinical Document Management responsibilities include eTMF Compliance, clinical SOPs maintenance and Inspection Readiness for all Larimar-sponsored clinical trials. Additionally, this position is responsible for progressing eTMF compliance and clinical records keeping. This position will ensure functional teams operate in compliance with GCP quality standards and global regulatory requirements. The position represents Clinical Records in internal process audits, GCP/GxP inspections, and enterprise initiatives impacting eTMF resources, GCP/GXP best practices. processes, and systems.
Primary Responsibilities
- Lead eTMF compliance through strategy, planning, and execution of inspection readiness programs.
- Lead study specific eTMF Plan and Index drafting and revisions.
- Provide guidance to functional teams to ensure eTMF compliance with applicable regulations and requirements.
- Analysis of eTMF data to proactively identify and alert the organization of eTMF quality or compliance concerns.
- Directly support internal process audits and global regulatory inspections as the eTMF subject matter expert.
- Advise on Corrective and Preventative Action (CAPA) remediation and resolution of eTMF issues identified through audits, inspections, and other compliance assessments.
- Develop and execute on eTMF metric strategy.
- Influence future eTMF direction and capabilities by identifying and leading activities which build efficiencies, automation, standardization, and adoption of best practices.
- Collaborate with key internal and external stakeholders to assess process alignment and prioritize procedural and eTMF system changes to ensure continued improvements and compliance.
- Represent Clinical Records in cross-functional projects, initiatives, and compliance forums.
- Serve as an ambassador of Good Documentation Practices to ensure compliance with global regulations, internal procedural documentation, and data integrity.
- Maintain clinical SOPs and other applicable Clinical Documents.
- Hire and manage resources as needed to support TMF compliance and inspection readiness.
- BA or BS and 10+ years' experience in compliance and trial master file in pharmaceutical/biotechnology industry.
- Excellent working knowledge of GCP regulations.
- Experience at the Sponsor level with front and backroom inspection operations.
- Ability to build strong relationships to foster a collaborative approach to proactive compliance activities.
- Document Records Management experience using electronic eTMF platforms.
- Strong verbal, written, communication, and interpersonal skills.
- Ability to travel 10 -20 percent as required
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