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Pharmaron · 2 days ago

Senior Manager, Clinical Data Manager

Somerset, NJ

Full-time

Onsite

Mid, Senior Level

$120K/yr - $140K/yr

6+ years exp

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. The Senior Manager, Clinical Data Manager is responsible for ensuring the integrity and accuracy of clinical trial data while leading data management teams and ensuring compliance with regulatory requirements.

BiotechnologyChemicalPharmaceutical

Hiring Manager

Jessica Banfield - Assoc CIPD

Responsibilities

Responsible for ensuring the integrity, reliability, and accuracy of clinical trial data

Ensure clinical data quality and consistency conform to regulatory requirements, SOPs, processes, and data standards

Ensure external data meets standards outlined in the data transfer specification

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

Ensure data/database programming and development apply CDISC or applicable standards throughout the trial

Follow and remain consistent with all Pharmaron Clinical policies and procedures

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

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

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

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

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

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

Ensure staff compliance with Pharmaron Clinical policies, SOPs, ICH-GCP, and regulatory requirements

Participate in project business bidding

Identify and implement process improvements; recommend improvement plans to senior management

Qualification

Clinical Data ManagementGCP KnowledgePeople ManagementRegulatory ComplianceData Quality AssuranceProcess ImprovementRisk ManagementTeam Collaboration

Required

Bachelors Degree with at least 6 years' experience within a data management role (>2 years' experience in people management), 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 GCP and other regulatory requirements for clinical trials

Demonstrated knowledge of the functions and activities of clinical trials

At least 2 years management experience