Clinical Data Specialist

Job#: 3022365

Job Description:

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients' digital visions.

Apex has an opportunity for an Clinical Data Specialist. For applicants who are interested in this opportunity, send your updated resume to .

Here are the details:

Position: Clinical Data Specialist

Location: Remote

Project Duration: 6 months

Rate: Negotiable Bases on Experience

JOB DESCRIPTION

The Clinical Data Specialist requires in depth knowledge and experience in clinical data management with demonstrated capabilities in coordinating data management activities across multiple studies. The Clinical Data Specialist contributes to data management process improvements and initiatives within the department and all aspects of the clinical data management lifecycle.

Responsibilities:

Assist with the creation and/or review study-specific Case Report Forms (CRFs) using device study knowledge and protocol specific information in collaboration with clinical team.

As applicable, contribute to the development of Case Report Form Library of common forms that can be used consistently across studies.

Support EDC database development(s).

Participate in the validation and User Acceptance Testing (UAT) of EDC databases.

Develop and/or review study-specific data management and database documentation, which may include Data Management Plan (DMP), CRF Completion Guidelines (CCGs), Annotated CRFs, Edit/Logic Check Specifications, and UAT Plans.

Collaborate with clinical team members to generate data review guidelines and perform data review and query generation/closure.

Prepare data for scheduled snapshots/database locks and perform archival activities upon study completion.

Attend study-specific team meetings and produce requested metrics, which may include query information or data trends.

Train Investigators and Coordinators on the EDC system, and CRF completion guidelines as needed.

Manage EDC user access for sponsor and site personnel.

Education and Experience

Bachelor's degree is strongly preferred

Requires 2+ years of clinical data and EDC experience

Strong computer skills with a proficiency with MS Windows based applications

Working knowledge of Good Clinical Practices (Google Cloud Platform), FDA regulations, and current industry practices related to the conduct of clinical trials including applicable ISO regulations for any trials conducted globally

Preferred Skills and Competencies:

Able to prioritize workload, assign realistic completion dates, and complete assignments on schedule

Excellent written and oral communications skills required

Comfortable with multiple Electronic Data Capture (EDC) Systems

Strong organizational skills and attention to detail.

Ability to work independently and manage multiple tasks in a fast-paced, changing environment.

Travel Requirements:

This position requires some travel up to 5% of the time.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.