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Pharmaron · 2 weeks ago

Clinical Data Manager

Somerset, NJ

Full-time

Onsite

Mid Level

$60K/yr - $75K/yr

3+ years exp

Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. The Clinical Data Manager ensures the integrity, accuracy, and compliance of clinical trial data, overseeing data quality, managing external data transfers, and leading project teams to provide high-quality data management services.

BiotechnologyChemicalPharmaceutical

Hiring Manager

Jessica Banfield - Assoc CIPD

Responsibilities

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

Ensure that clinical data quality and consistency conform to applicable regulatory requirements, SOP(s), processes, and data standards

Ensure that external data conforms to standards outlined in the data transfer specification

Ensure all data management activities are compliant with GCP, relevant regulatory requirements, and SOP(s) of Pharmaron Clinical and/or Sponsor

Ensure that data/database programming and development follow and apply CDISC or applicable standards throughout the duration of a clinical trial

Act as the Lead Data Manager for clinical trials, arrange for resources and assess their workload

Identify the work scope of the study and create a study timeline based on the clinical protocol

Participate in internal/external functional meetings

Oversight of all data management tasks related to a clinical trial as mandated by the scope of work

Monitor the project and ensure trial deliverables meet expected timelines and quality standards

Participate in internal/external audits and regulatory inspections

Provide risk management assessments for data management deliverables

Lead clinical data management project teams in the delivery of services to clients to ensure the provided service is consistent with client needs, expectations, and contractual obligations

Qualification

Clinical Data ManagementGCP ComplianceCDISC StandardsData Quality AssuranceStudy ManagementRisk ManagementVendor ManagementTeam LeadershipCommunication Skills

Required

At least 3 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 GCP and other regulatory requirements for clinical trials

Demonstrated knowledge of the functions and activities of clinical trials