Associate External Data Management Director

Exelixis•Alameda, CA

1d•$160,000 - $226,500•Onsite

About The Position

The Associate External Data Management Director is responsible for managing the processing of external and/or local lab data received by Exelixis throughout the clinical trial lifecycle. They provide subject matter expertise in external data handling of various external data sources (ie: central laboratories, pharmacokinetic, immunogenicity, pharmacogenetic and biomarker samples, etc.) to internal cross-functional teams and external stakeholders to ensure high quality data. They provide support to the Lead Data Manager (LDM), Clinical Operations as well as the Biosamples managment group with the review, maintenance, and management of external vendor. Leads functional service provider resources in a matrixed environment.

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.
Results-driven team player who thrives in collaborative environments and builds positive relationships.
Highly detail-oriented, with a creative mindset focused on process optimization.
Excellent organizational and communication skills.
Ability to analyze and resolve issues, prioritize tasks effectively, and propose actionable solutions.
Typically requires a minimum of 11 years of related experience and/or combination of experience and education/training.
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.
The ability to problem solve and have people/project leadership skills.
Knowledge of GCP is essential.
General knowledge of FDA regulations that govern the execution of clinical trials and Electronic Data Capture (EDC) systems required.
Has extensive experience in relevant industry/profession and area of specialization.
Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
Identifies and implements methods and procedures to achieve results.
Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
Performs a variety of complicated tasks with a wide degree of creativity and latitude.
Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
Has good general knowledge of other related disciplines.
Applies strong analytical and business communication skills.
Demonstrated Project Management skills.
Excellent verbal and written communication skills and interpersonal skills are required.

Nice To Haves

Preferred experience in oncology trial management.
Expertise in CDASH/CDISC standards preferred.

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 setvice 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.