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Pharmaron · 3 weeks ago

Senior Clinical Data Manager

Franklin, NJ

Full-time

Onsite

Mid, Senior Level

$90K/yr - $100K/yr

4+ years exp

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. The Senior Clinical Data Manager will ensure the integrity and accuracy of clinical trial data while overseeing data management tasks and leading project teams to meet client needs.

BiotechnologyChemicalPharmaceutical

Responsibilities

Ensure the integrity, reliability, and accuracy of clinical trial data

Maintain clinical data quality and consistency in line with regulatory requirements, SOPs, processes, and data standards

Verify external data conforms to data transfer specifications

Ensure all data management activities comply with GCP, regulatory requirements, and Pharmaron Clinical/Sponsor SOPs

Apply CDISC or applicable standards to data/database programming throughout the trial

Adhere to Pharmaron Clinical policies and procedures

Act as Lead Data Manager for clinical trials: arrange resources, assess workload, define study scope, and create timelines

Oversee all data management tasks for assigned trials; monitor deliverables to meet timelines and quality standards

Participate in internal/external meetings, audits, and regulatory inspections

Communicate effectively with internal teams, vendors, and clients; provide risk management assessments

Mentor and train team members; perform data management tasks as needed

Lead project teams to deliver services aligned with client needs and contractual obligations

Develop and improve clinical data management SOPs and processes; recommend improvements to senior management

Qualification

Clinical Data ManagementGCP ComplianceCDISC StandardsData Quality AssuranceDatabase SetupVendor ManagementRisk ManagementTeam Leadership

Required

Bachelor's Degree with at least 4 years' experience within a data management role, understanding of processes including study management, vendor management, CRF design, database set-up, edit check specification, DMPs, and data cleaning activities up to and including database lock

Demonstrated knowledge of the functions and activities of clinical trials

Demonstrated knowledge of GCP and other regulatory requirements for clinical trials