Associate External Data Management Director

Associate External Data Management Director

Requirements

• BS/BA degree in related discipline and a minimum of 11 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
• PhD in related discipline and a minimum of 5 years of related experience; or,
• Equivalent combination of education and experience.
• Clinical or biological laboratory experience with a focus on processing and/or analyzing biological samples.
• Familiarity with oncology laboratory terminology and genomic biomarker and pharmacokinetic/pharmacodynamic endpoints derived from tissue and blood samples is essential.
• Strong understanding of FDA and ICH/GCP regulations and guidelines.
• A minimum of 7 years of clinical data management experience is also required in the pharmaceutical industry or clinical trials.
• A minimum of 4 years in a project leadership role.
• At least 5 years of experience sFTP and Data Transfer Automation.
• At least 5 years of experience Vendor Management.
• Extensive clinical trial management experience from study initiation through to closeout, with expertise in oncology and/or precision medicine early-phase drug development.
• Experience with Electronic Data Capture (EDC) is required.

Responsibilities

• Develop and maintain strong, collaborative relationships with internal study execution/management teams, CROs, laboratory service providers, and other key stakeholders.
• Develop the Data Transfer Plan (DTP), including the Data Quality Review reconciliation section for the external vendor data transfer(s), obtain final approvals and file document to the Trial Master File (TMF) as applicable.
• Develop and document external data edit checks and reports in the edit check template, obtain approvals and perform QC/UAT to verify the checks and reports are functioning properly.
• Collaborate with external functional service provider counterparts for study expectations including milestones, deliverable timelines, communication expectations, etc.
• May participate in review of external vendor Statement of Work (SOW) for study scope, and ensure all protocol specified parameters are present as applicable.
• Ensure electronic external vendor data transfers contain all protocol specified parameters, is in correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP).
• Review external data discrepancies generated by edit checks and reports and perform subsequent query management to resolve data issues.
• Maintain appropriate documentation of data issues in both study and vendor logs and follow outcome to resolution.
• May assist with review of draft protocols from an external data perspective and assist with review of eCRF design per protocol parameters.
• Work with other study team functions to gather feedback and address any issues that could impact data review or analysis.
• May work with clinical staff to obtain and QC local laboratory ranges and verify the normal ranges are properly attached to the subject results in the local lab data. Participate in study team and department meetings as applicable.
• Effectively plan and support multiple high quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested.
• Provide guidance/mentoring to junior team members as appropriate.
• All other duties as needed or assigned.

Preferred Qualifications

• Preferred experience in oncology trial management.
• Familiarity with oncology laboratory terminology and genomic biomarker and pharmacokinetic/pharmacodynamic endpoints derived from tissue and blood samples is essential.
• Expertise in CDASH/CDISC standards preferred.