Clinical Data Manager

Position Title:

Clinical Data Manager

Work Location:

Maple Grove MN
Assignment Duration: 06 Months

Top Skills Needed:

• Analytical and critical thinking skills along with related prior data management experience. Great communication skills with a focus on collaboration.
• Confident in leading discussions and managing complex regulated studies.
• Experience in effectively influencing a team decision to the desired outcome.

Experience Needed:

• 5 years in clinical operations or healthcare related field.
• Education and work experience in data management, project management, life sciences and/or technical field.
• Knowledge of Good Clnical Practice and global regulations for investigational studies.

Education:

• Education Level-Bachelor's degree
  - Major/Field of Study
  - Biology, Health Sciences, Mathematics, Computer Science, or equivalent

Licenses and

Certifications:

• None required;
  Certified Clinical Data Manager desired.

Assists in the ongoing evaluation of risk involving in-depth review of protocol and plan documentation, discussion and validation of risk-related findings with cross-functional workgroup, and the development of systems and process-based controls to mitigate identified risks. These responsibilities include the below under the direction and guidance of a manager:
Leading cross-functional teams during protocol development to identify and document those data which are critical to the reliability of study results and the protection of human subjects
Managing the development and revision of the critical processes (e.g. CRF design, edit checks, data listings, and clinical database setup) by which those data will be captured and managed throughout the clinical investigation
Identifying and evaluating residual risks to critical study data and supervising the development of additional mitigations including focused data cleaning and quality activity, targeted site instruction, and study-specific Central and Site Monitoring plans
Leads the Clinical Project Team through the development of Case Report Forms and partners with the Study Database Manager through study database development and release, including identifying, programming and testing edit checks.
Conducts review and analysis of subject data as it accumulates, resolving discrepant or aberrant data points via individual queries to study sites, as well as the identification of systemic and/or significant data quality issues requiring escalation; manages escalation efforts and drives them to resolution in partnership with Project Management, Site Management, Clinical Science, Biometrics, Safety, and organizational leaders.
Manages progress towards data cleaning and data freeze/lock targets for regulatory submission, and other business needs as identified by the Clinical Project Team.
Manages, with dedicated support of the Clinical Data Coordinator, the study-wide issuance and resolution of discrepancies over the study lifecycle, including root cause analysis of discrepancy trends requiring clinical or complex logical judgment, and the development of system-level countermeasures and iterative process improvement.
Contributes to the maintenance of data review standards and best practices, ensuring adherence informed by therapy-specific expertise.
Leads proactive partnership, on both an ad hoc and period/prescribed basic, with field and study team personnel, presenting findings and issues uncovered during central monitoring and data review activities, devising and documenting appropriate resolution and escalation strategies, and managing the overall health of data quality and study conduct through milestones and deliverables over the lifecycle of the study.