Senior Clinical Data Operations Manager

Description

Effectively supervises the Infectious Disease Clinical Research Program's (IDCRP) Data Coordination Center (DCC):

Ensures effective data management operations through staff oversight and training, creating a climate of cooperation and support, and promoting connectivity among the DCC and internal and external collaborators.

Ensures the DCC meets operational objectives for IDCRP's study protocols in coordination with the Chief of Data Operations, Center Operations, Science Directorate, and Principal Investigators.

Manages DCC functional Team Leads and staff to prioritize tasks and allocate staff to ensure delivery of expected products on an appropriate timeline within a highly dynamic environment.

• Oversees the DCC operations in support of new and ongoing clinical research protocols:

Manages and ensures training of DCC staff in proper data collection and management, hardware and software, and implementation.

Maintains external awareness of best practices within the clinical data management space.

Supervises DCC staff in following Good Clinical Practices and Good Clinical Data Management Practices.

Leads the development, maintenance, and governance of DCC standards by providing oversight and guidance on general policies, standard operating procedures, and quality assurance processes for data collection, abstraction, analysis, submission, and reporting.

Completes and oversees analysis of protocol documents to generate study database design specifications including CRF/eCRF design, visit schedule, edit checks, system notifications, query logic, user role setup, randomization triggers, supply triggers, and medical coding.

Plans, leads, and effectively supervises database setup activities, ensuring appropriate database documentation.

Develops data management SOPs as well as clinical trials data management best practice implementation guidelines; ensures staff training and compliance.

Ensures, reviews, and quality controls against associated project protocol, NIAID requirements, CRF standards templates, Good Clinical Data Management Practices (GCDMP), and where applicable CDISC Clinical Data Acquisition Standards Harmonization (CDASH) standards.

Oversees the development of data quality processes to guide users through data entry and prevent erroneous data entry and values.

Performs database validation as well as User Acceptance Testing (UAT), and documents databases in accordance with programming standards and validation procedures.

Supervises setup and review of data management documentations and operational activities.

Develops clinical data management training and mentorship programs as well as presents at clinical data management training events and workshops.

Act as Subject Matter Expert (SME) of clinical data management techniques, processes, systems, and their implementation.

Supervises direct reports and mentors staff.

Skills

data management, clinical research, management skills, REDCap, oracle, sas

Additional Skills & Qualifications:

Bachelor's Degree required, Master's degree preferred.

More than 10 years of experience required - this can be within anything ranging from data management, programming, biostats, etc.

Minimum of 5 years of supervisory and operational management experience required.

Certified Clinical Data Manager (CDM) certification preferred.

Expert in multi-site clinical research project/protocols with regard to data management through all phases of protocol development, execution, and close out.

Experience with the administration and utilization of electronic data capture (EDC) systems for collection of clinical research data; REDCap experience preferred but not required.

Possess broad technical knowledge in relevant programming languages and data systems (e.g. SAS, Oracle, SQL, PHP), as this position is responsible for the supervision of DCC staff implementing technical components required to support data acquisition, analysis, and reporting for complex projects.

Ability to manage teams located around the continental United States and to work with Program staff and investigators located around the world.

Proficiency effectively using collaborative software such as MS Teams in support of data operations.

Strong clinical data management capabilities.

Experience with EDC system administration, data collection instrument development/programming, and database management.

Excellent communication skills.

Experience managing data management operations and supervising data management operations staff.

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 ~~~ (~~~) for other accommodation options.