Project Manager
Indianapolis, Indiana
Direct Portfolio Project Manager
Remote
The Direct Portfolio Project Manager will be a highly organized and detail-oriented Direct Portfolio Project Manager with a strong focus on records management and retention. This role will be responsible for overseeing the development, implementation, and management of records retention strategies for clinical trials, ensuring compliance with regulatory guidelines, company policies, and industry standards. The successful candidate will play a critical role in maintaining accurate, complete, and up-to-date trial records while ensuring the efficient management of clinical trial documentation throughout its lifecycle.
Direct Portfolio Project Manager Responsibilities:
Records Management
Direct Portfolio Project Manager Qualifications:
Remote
The Direct Portfolio Project Manager will be a highly organized and detail-oriented Direct Portfolio Project Manager with a strong focus on records management and retention. This role will be responsible for overseeing the development, implementation, and management of records retention strategies for clinical trials, ensuring compliance with regulatory guidelines, company policies, and industry standards. The successful candidate will play a critical role in maintaining accurate, complete, and up-to-date trial records while ensuring the efficient management of clinical trial documentation throughout its lifecycle.
Direct Portfolio Project Manager Responsibilities:
Records Management
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- Develop and implement a comprehensive records management strategy for clinical trials, ensuring compliance with applicable regulatory requirements (e.g., FDA, ICH-GCP, 21 CFR Part 11).
- Oversee the classification, storage, and retrieval of clinical trial documents, including case report forms (CRFs), investigator brochures, informed consent forms, and all other trial-related documentation.
- Maintain a centralized, easily accessible, and compliant filing system for all trial records, both paper and electronic.
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- Ensure all trial records are retained for the appropriate duration per regulatory requirements, organizational policies, and best practices.
- Monitor document retention timelines and manage the disposal or archiving of records once retention periods are complete.
- Provide guidance on document retention requirements and best practices to cross-functional teams and stakeholders involved in clinical trials.
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- Work closely with clinical operations, regulatory, legal, and quality assurance teams to ensure proper handling of records during the trial lifecycle.
- Ensure that clinical teams are well-informed about proper document storage and retention policies throughout the trial process.
- Coordinate with internal and external stakeholders to address any record-related queries and ensure smooth communication regarding documentation management.
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- Perform regular audits and inspections to ensure that records are accurately maintained and compliant with internal and external standards.
- Collaborate with the clinical trial team to conduct root-cause analysis and corrective actions for any records-related discrepancies or non-compliance issues.
Direct Portfolio Project Manager Qualifications:
- Bachelor’s degree in Life Sciences, Nursing, Clinical Research, or a related field.
- 3+ years of experience in clinical trial management or clinical operations, with at least 2 years focused on records management or retention preferred
- Strong knowledge of regulatory guidelines for records retention in clinical trials (e.g., 21 CFR Part 11, ICH-GCP, FDA, and EMA regulations).
- Experience with Clinical Trial Management Systems (CTMS), electronic trial master files (eTMF), or document management systems.
- Excellent organizational skills, attention to detail, and the ability to manage multiple tasks effectively.
- Ability to collaborate with cross-functional teams and communicate effectively with internal and external stakeholders.
- Strong problem-solving skills and the ability to identify, assess, and address record-related challenges.
- Familiarity with audit processes, quality control, and regulatory compliance inspections.
- Proficiency in Microsoft Office Suite and other relevant software tools.
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