Position Overview:

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 Analyst 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 3+ years of clinical data and EDC experience
• Strong computer skills with a proficiency with MS Windows based applications
• Working knowledge of Good Clinical Practices (GCP), 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.

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote

Additional Information:

The US base salary range for this full-time position is $101,475.00 - $152,212.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.