Manager/Senior Manager, Clinical Documentation Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and cultivate a segment of the Clinical Documentation (eTMF) team, enhancing performance, workload prioritization, and professional growth.

• Promote operational excellence and consistency in eTMF execution across designated studies.

• Offer daily guidance and mentorship on documentation processes and quality standards.

• Ensure that eTMF activities comply with ICH-GCP, GxP, and relevant local regulatory standards.

• Collaborate with Quality Assurance and study teams to uphold compliance across assigned projects.

• Assist with internal and external audits, including preparation of documentation and responses to findings.

• Enhance and implement eTMF processes, SOPs, work practices, and templates.

• Identify process deficiencies, suggest improvements, and back continuous enhancement initiatives.

• Analyze eTMF quality metrics, recognize trends, and assist in corrective actions.

• Provide training on eTMF and communicate updates on procedures and best practices.

• Act as a resource for Good Documentation Practices, TMF Reference Model alignment, and eTMF guidance.

• Monitor eTMF completeness, accuracy, and risk indicators; escalate issues to the Senior Director when necessary.

• Conduct regular eTMF quality assessments and support reconciliation and close-out activities.

• Aid in the implementation, maintenance, and user adoption of document management systems like Veeva Vault and SharePoint.

• Serve as an eTMF system super-user, providing guidance and troubleshooting assistance.

• Ensure compliant document archiving in accordance with SOPs and study requirements.

• Assist with client qualification or project-specific audits and follow-up actions.

• Ensure compliance with client SOPs and regulatory standards.

• Be prepared for travel of up to 10%.

• Uphold and promote Ora’s quality system, data integrity standards, and business ethics.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a related field, or equivalent professional experience.

• Over 5 years of experience in clinical operations, clinical documentation, quality, or a related role within pharmaceutical or CRO settings.

• At least 2 years of experience with eTMF or records management systems.

• For Senior Manager level: a minimum of 3 years of experience managing people.

• For Manager level: at least 1 year of experience in people management, team leadership, or supervisory roles.

• Familiarity with Veeva Vault eTMF or other document management systems (Veeva Vault preferred).

• Strong comprehension of ICH-GCP, TMF Reference Model, and documentation best practices.

• Capability to manage workloads, adhere to timelines, and function under time constraints.

• Proficient analytical and problem-solving abilities, including the interpretation of quality trends.

• Clear and consistent writing skills; experience in contributing to SOPs or process documentation.

• Ability to support organizational changes and work effectively in a matrix environment.

• Exceptional verbal and written communication skills, including the ability to present to cross-functional teams.

• Willingness to travel up to 10%.

• Full-time employees are required to work a minimum of 30 hours per week for benefit eligibility.

🏝️ Benefits

• Comprehensive Medical, Dental, and Vision healthcare options starting on day 1.

• Flexible PTO.

• Unlimited sick leave.

• 14 company-paid holidays.

• 401K plan through Fidelity with company matching.

• Adoption and fertility assistance.

• 16 weeks of paid parental leave.

• Company-paid life and disability insurance.

• Remote workspace and wellness reimbursement.

• Employee Assistance Program.

• Opportunities for career development.

• Chances to collaborate with colleagues globally.

• Opportunity to research new ophthalmic therapies that have a global impact on patients.