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.
ESSENTIAL DUTIES AND 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.
SUPERVISORY RESPONSIBILITIES:
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- 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.
Experience/The Ideal for Successful Entry into Job:
- 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.
- Preferred experience in oncology trial management.
- 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.
- Familiarity with oncology laboratory terminology and genomic biomarker and pharmacokinetic/pharmacodynamic endpoints derived from tissue and blood samples is essential.
- Experience with Electronic Data Capture (EDC) is required.
Knowledge/Skills:
- 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.
- Expertise in CDASH/CDISC standards preferred.
- 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.
JOB COMPLEXITY:
- Utilizes appropriate CDM concepts and resources to solve moderately complex technical CDM issues.
- Works independently and consults with management on decisions affecting project delivery as appropriate.
- Drives the completion of milestones associated with specific projects. Failure to achieve results or erroneous decisions or recommendations will cause delays in program. schedules and may result in the allocation of additional resources.
- Regular inter-organizational and outside contacts on routine matters.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
- Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
- Networks with key contacts outside own area of expertise.
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Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $160,000 - $226,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
If you have a disability and need an accommodation in relation to the recruiting process, please email us at: ApplicantAccommodations@exelixis.com.
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.