Description:

POSITION SUMMARY

The Clinical Data Specialist III (CDS III) independently plans, conducts and reports the data management portion of large, complex or international projects and provides leadership on the value and best practices for data integration processes. The CDS III provides the expert leadership for defining data management project requirements, considerations and effective implementation options. The CDS III position is an experienced manager supporting Clinical Data Management (CDM) teams, coordinating projects, facilitating infrastructure initiatives and participating in business development activities. The CDS III may perform other CDS level and Program Manager responsibilities on a project.

WORK PERFORMED The CDS III independently plans and manages all project related data management activities to include project contracts and sponsor communication. The projects include international with multiple collaborators, partners or sub-contractors, and projects involving new technology

• Directs internal and external project team meetings that may include cross-functional groups, sponsors and external stakeholders (e.g., data management team meetings, on-line review).
• Oversees collaboration with project stakeholders on requirements and workflow of the CDMS (e.g., database, integrations, systems).
• Oversees database design and data validation checks with project stakeholders.
• Supervises collaboration with project stakeholders on best practices for data cleaning requirements and requirements for reports/views, listings, quality control checks, alerts, data reconciliations and integrations.
• Develops, programs and unit tests prototype eCRF screens and data validation checks.
• Manages collaboration with sponsor and statistician to implement appropriate controlled terminology, standards or use of sponsor data structures.
• Manages development, updates and maintenance of specifications for project reports/views, listing, quality checks, alerts, data reconciliation requirements and integrations.
• Oversees the programming and testing schedule in collaboration with CDM Technical Services and project stakeholders.
• Supervises review and approval of testing plan and testing results, and release of components into the production environment.
• Oversees performance and documentation of quality control testing, user acceptance testing (UAT) and production qualification on components of the CDMS; oversees UAT with project stakeholders.
• Supervises all production activities on a project, including data cleaning, CDMS defects and changes, and data export services.
• Works with Program Managers to adequately resource project needs.
• Leads departmental initiatives.
• Coaches, mentors, and helps provide support to new project team members on project tasks.
• Participates in screening, interviewing and hiring of team members.
• Participates in performance review via self-assessment, personal goal-setting and providing feedback about colleagues.
• Evaluates coworkers’ performance to provide input into annual evaluations.
• Completes required departmental and project training; maintains a working knowledge of requirement trainings.
• Oversees collaboration on project lock requirements and activities during closeout.
• Supervises the management of the project lock checklist.

Skills:

Data, Management, CDM, Lead, Manager, Inform, RAVE, Clinical data, Data management, Edc, Data entry, medidata rave, Data Manager, Clinical, Late Phase, clinical research, vendor management, clinical trial management

Top Skills Details:

Data,Management,CDM,Lead,Manager,Inform,RAVE,Clinical data,Data management,Edc,Data entry,medidata rave

Additional Skills & Qualifications:

Project Management

Contributes to the data management portion of the scope of work and protocol.

Provides input and assistance to Program Manager for scope of work changes.

Oversees projections for project data management work.

Maintains accountability to the Project Lead for data management deliverables and timelines.

Manages internal and external customer expectations.

Risk Assessment-Proposes solutions to project risks; collaborates with the Project Leader and/or Program Manager to manage risk.

Communication -Oversees communication with Project Leader, project team, sponsor and project stakeholders regarding project data management items.

Timelines -Oversees CDM project specific timelines.

Coordinates with cross-functional team to develop and manage project timelines.

Data Coordination

EDC Support - Oversees processes in support of EDC account management on projects.

Oversees coordinate and resolution of project integration issues. (e.g., IxRS, SADI, data load issues).

Manages project related issues.

Oversees project lock procedures for systems within the CDMS (e.g., EDC database, integrations).

Audits Supports internal and external audits; develops and oversees execution of corrective action plan.

Stays current with applicable regulations and guidance.

Project Documentation

Supervises maintenance of project documentation in a centralized location for the duration of the project; to include, but is not limited to, a project profile, specifications, testing, and project data management training.

Supervises maintenance of project documentation in a centralized location for the duration of the project; to include, but is not limited to, a project profile, specifications, testing, and project data management training.

Meetings - Directs internal and external project team meetings that may include cross-functional groups, sponsors and external stakeholders (e.g., data management team meetings, on-line review).

Experience Level:

Expert Level

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.