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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced knowledge in records management and compliance with regulatory guidelines such as ICH, GCP, and GLP. Exhibits strong leadership and organizational skills to effectively manage project teams and ensure quality in records retrieval and staff training.
Highest-signal resume keywords
Records ManagementLeadership SkillsRegulatory ComplianceMicrosoft Office Suite ProficiencyProblem Solving
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Records ManagementRegulatory ComplianceQuality AssuranceData AnalysisProject Management
Soft Skills
Leadership SkillsWritten CommunicationVerbal CommunicationOrganizational SkillsTime Management
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPoint
Industry Keywords
Good Clinical PracticeGood Laboratory PracticeInternational Conference on HarmonizationHealth CareScientific Discipline
About the role
Key responsibilities & impact- Manage records and coordinate with project teams regarding information and records issues
- Serve as the primary client contact for records/retrieval issues
- Coordinate and deliver on the retrieval of records requested by users
- Prepare closed studies for transfer to final destinations
- Monitor records filing accuracy and compliance with QI and/or client file plans/SOPs
- Recommend changes or revisions to records retention schedules
- Participate in selection and onboarding of new staff, including candidate review and interviewing
- Conduct onboarding training with Human Resources and Learning and Development
- Ensure staff have proper materials, systems access, and training
- Oversee training plans, SOP review, and mentored training experiences
- Allocate project resources by assigning appropriately trained staff
- Manage quality through regular review and evaluation of work products
- Identify quality risks and create corrective action plans
- Monitor workload and quality metrics through regular review and reporting
- Manage staff according to organizational policies and applicable regulations
- Plan, assign, and direct work; appraise performance; guide professional development; reward and discipline employees; address employee relations issues; and resolve problems
- Perform other duties as assigned
Requirements
What you’ll need- Bachelor's Degree in health care or other scientific discipline or equivalent combination of education, training and experience
- Advanced knowledge in records management or technically-related areas
- Knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), relevant local laws and applicable regulatory guidelines
- Proficiency in Microsoft Word, Excel and PowerPoint
- Strong leadership skills and ability to manage and lead others
- Strong written and verbal communication skills including good command of English
- Excellent organizational and problem solving skills
- Effective time management skills and ability to manage competing priorities
- Ability to establish and maintain effective working relationships with internal and external clients
- Ability to perceive and analyze problems, develop solutions, and make sound management decisions
- Ability to achieve productivity despite time pressure constraints
- Ability to handle multiple tasks and projects within defined timelines and balance competing priorities
- Ability to perform writing and keyboarding involving repetitive finger motions and sit for prolonged periods
- May require occasional travel (up to ~20%)
Benefits
Comp & perks- Incentive plans, bonuses, and/or other forms of compensation may be offered
- Health and welfare benefits
- Supportive culture
- Collaboration-focused team environment
- Commitment to excellence in clinical research