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Associate Director, Clinical Data Management

4 months ago

Gaithersburg, United States Actalent Full time

Associate Director level opportunity with a CRO. This is a hands-on position with oversight responsibilities. Will have 3-5 direct reports.

Position Summary:

The Associate Director, Clinical Data Management will be responsible for all Data Management tasks from study start-up to database lock for assigned studies. Lead multiple large and complex studies, performing and delegating tasks as appropriate. Effectively interact with sponsors and manage vendors. Mentor junior personnel. Develop SOPs and study-specific procedures.

Responsibilities:

* Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures
* Work with DB programmers to design (e)CRFs and edit checks in EDC system for complex studies
* Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules
* Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming
* Coordinate with sponsor and vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation
* Perform coding of adverse events, medical conditions and medications
* Perform SAE reconciliation
* Lead and perform pre-lock and data lock tasks
* Prepare training materials and user guides for EDC data collection tools, deliver user training
* Participate in client and team meetings as required, providing status updates and advising on best practices as appropriate
* Design, generate, and review status metric reports, identifying and communication trends as needed
* Provide regular status updates, keeping cross-functional study team, management, and sponsors informed of any changes
* Provide study specific training for team members and end users, as appropriate
* Implement technical solutions, new tools, and resolve complex issues
* Lead large and complex projects
* Develop SOPs and manuals

Additional Skills & Qualifications:

* Minimum BS in a scientific or health related field or equivalent
* Minimum 9 years of experience in Clinical Data Management
* Must have experience working at a Clinical Research Organization
* Knowledge of medical terminology and pharmaceutical notation
* Expertise with EDC systems, such as Medidata Rave, InForm, Medrio
* Excellent organizational and time management skills
* Strong collaboration and leadership skills

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

* Hiring diverse talent
* Maintaining an inclusive environment through persistent self-reflection
* Building a culture of care, engagement, and recognition with clear outcomes
* Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.