Sr. Manager, Clinical Document Control and Training
Provide leadership and management oversight of clinical document control and clinical training, including managing the day-to-day operations of the clinical documentation archive, the team responsible for managing the TMF/eTMF , and maintenance and tracking of training records. Partner with Clinical Development, Quality Assurance, and Regulatory Affairs to enable the development and maintenance of Standard Operating Procedures (SOPs) and clinical records. Ensure Clinical Development is appropriately trained on SOPs. Implement process improvement initiatives such as e-sign, system improvements for eTMF to ensure continued adherence to regulatory requirements and inspection-readiness Develop and maintain Trial Master File SOPs. Responsibilities
Clinical Document Control and Management
Clinical Document Control and Management
- Ensure the management of the day-to-day operations of the clinical document archive, ensuring all documents are organized, maintained, and tracked in accordance with established SOPs and regulations.
- Develop and manage processes and procedures for Clinical Development in relation to training and clinical document management procedures may include SOPs, work instructions, guidelines, etc.
- Provide guidance and advice in document development and control methods as needed.
- Oversee the development and implementation and continuous process improvement of and training for an electronic clinical document management system (eTMF)
- Partner with the clinical development leadership and the Quality Assurance (QA) group to establish and maintain a robust clinical document control system.
- Lead the clinical document control team in preparing for and participating in an audit and/or regulatory inspection.
- Recruit, mentor, manage, and retain a department of clinical document control professionals, including full-time employees and consultants.
- Author and/or review SOPs for content, completeness, regulatory compliance, formatting, and consistency with other related documents. Subject matter expert for several SOPs, work instructions, and guidelines relevant to trial master file and clinical document control.
- Oversee the review and approval process of Clinical SOPs, work instructions, guidelines, and other clinical documents.
- Conduct training for Clinical SOPs. Ensure the appropriate training is acquired, respond to staff training gaps and needs, and administer training tailored to Clinical staff on an on-going and as-needed basis.
- Work with Clinical and QA management to set compliance training priorities.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Other duties as assigned.
- Bachelor’s degree with 8+ years’ experience with clinical operations, clinical documents, and SOPs, or equivalent work experience and at least 3 years’ management experience.
- An effective manager who will work proactively to drive results.
- Experience in developing SOPs and administering training is a must.
- Knowledge and experience in current eTMF practices and systems is a must
- Knowledge of clinical e-sign policies, procedures and implementation is highly desired
- Excellent written communication skills and proven ability to translate technical data into concise narrative/summary.
- Current knowledge of regulations and clinical development process.
- Effective interpersonal and verbal communication skills to efficiently disseminate information within Clinical as well as other functional areas as appropriate.
- Organized and highly developed project and time management skills to execute on deliverables.
- Collaborate effectively with the Clinical Development functional teams, cross-functional team members, and external partners.
- Proficient computer skills, specifically with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
- Ability and desire for problem solving and decision making in a cross-functional team setting.
- High attention to detail, excellent organizational skills, and ability to work on multiple projects with tight deadlines.
- Flexible, high level of integrity, action- and goal-oriented.
- Enjoy a fast-paced, team-oriented, and collaborative environment.
- Proven ability to establish collaborative working relationships; team-oriented, but able to work independently.
- Experience with electronic filing system preferred.