The Senior EDS Lead develops the Clinical Data Management Plan, obtain final approvals and file document to the Trial Master File (TMF) as applicable. Responsible for communication and managing relationship with external vendor and sponsor counterparts for study expectations including milestones, deliverable timelines, communication expectations, etc.

What to Expect

• 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) or sponsor equivalent.
• Develop and document external data edit checks and reports in the edit check template or sponsor equivalent, obtain approvals and perform QC/UAT to verify the checks and reports are functioning properly.
• 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 increasingly complex and high quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested.
• Complete Covance and sponsor (if applicable) trainings in a timely manner and perform job functions in accordance with set guidelines.
• Provide guidance/mentoring and assist with training of junior or new team members as appropriate.
• May assist with evolving external data management practices or optimizing current processes for efficiency and accuracy.
• 100% Remote anywhere is US or Canada

Education/Qualaifications

• University / college degree (life sciences, health sciences, information technology or related subjects preferred).
• Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree.

Experience

• 5+ years prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries to include data management or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
• Project Management experience strongly preferred. Basic understanding of medical terminology a plus.
• Strong organizational, planning, and critical-thinking skills.
• Well-polished, inclusive, and engaging communication skills (written and verbal) to support effective interactions with sponsors and internal colleagues.
• Strong negotiation skills to facilitate, guide, influence, and produce a unified approach within a global, cross-functional environment.
• Ability to handle multiple tasks in a timely and professional manner under demanding conditions.
• Ability to use standard Microsoft suite of software products.
• Strong technical aptitude.
• Ability to maintain confidentiality of data and information during interaction with staff at all levels.
• Understanding of ICH-GCP principles.

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