Lead Clinical Data Manager

Orcabiosystems

Remote

Who this role is best for

Aimed at senior clinical data managers who specialize in end-to-end trial data management and CDISC compliance within biotechnology.

Best fit for

Experienced clinical data managers comfortable with EDC builds and database locks.
— “responsible for all aspects of clinical trial data management”
Professionals adept at ensuring data accuracy and CDISC compliance.
— “responsible for accuracy, consistency, completeness and CDISC compliance”
Individuals who thrive in cross-functional clinical operations teams.
— “operate as a key member of the Clinical Operations team”

Things to consider

Full ownership of data management from study start to close.
— “from study start up through database lock and study close”
Requires expertise in both EDC and non-EDC data sources.
— “ensure optimized data collection, flow and access across EDC and non-EDC data sources”

How to stand out

Highlight specific examples of leading database locks in past roles.
— “database lock and study close”
Demonstrate experience with CDISC compliance in clinical databases.
— “CDISC compliance of all clinical databases”
Showcase your ability to manage data cleaning and query resolution.
— “study data cleaning and reconciliation, query issue and resolution”

Pace · SteadyCollaboration · HighAutonomy · MediumDecision Impact · TeamLevel · Senior

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

accurate and complete clinical databases
successful database locks
compliance with regulatory standards

Typical background

clinical data management experienceknowledge of cdisc standards

Skills & requirements

Required

Clinical Data ManagementEdc BuildData CleaningQuery ResolutionCdisc Compliance

Preferred

Clinical Trial ExperiencePharmaceutical Industry Knowledge

Stack & domain

Clinical Trial Data ManagementEdc BuildUatData CleaningQuery ResolutionDatabase LockCdisc ComplianceClinical DatabasesAccuracyConsistencyCompletenessTeam CollaborationClinical TrialsData ManagementHealthcareBiotechnology

About the role

Original posting from Orcabiosystems via Lever

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Summary:
The Lead Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close. This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks. They will ensure optimized data collection, flow and access across EDC and non-EDC data sources. They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases. The role will operate as a key member of the Clinical Operations team.

Source: Orcabiosystems careers (Lever)