Sr Data Team Lead

Senior Data Team Lead

Independently manage endtoend delivery of data management services for single/multiservice projects ensuring quality deliverables on time and within budget to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs.

Provide leadership and vision to the team in the areas of project planning execution and closeout; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL) Program Lead Customer Site Manager and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs) applicable regulatory guidelines SOPs policies and where available CDM guidance documents.

Essential Functions

Client Management: Serve as primary point of contact for customer on data management deliverables

Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies/programs of global studies Provide leadership and senior support to DTLs on multiple large global studies.

Provide project management expertise working with customer data managers key decision makers and internal team members to manage continuous process improvements issue escalation workload projections and provide technical expertise

Lead direct negotiations with customer timelines financial process resources. Maintain strong customer relationships. Ensure open communications with customer and IQVIA management to independently manage and meet contractual obligations.

Service Management: Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables

Provide training and development on data management expertise to junior team members. Establish strong communications with Data Operations team functional leads project managers and all other stake holders

Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects

Serve as the escalation point for unresolved data issues. Independently work with client data managers vendors internal team members for resolution

Create and/or review and signoff on all data management plan (DMP) documents. Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW

Implement proactive quality management plans across multiple projects/programmes/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions

Ensure timely followup and resolution of compliance issues. Present at professional conferences and/or publish articles in professional journals

Provide review and expert opinion in developing revising and maintaining core operating procedures and work instructions. Perform other duties as directed by the functional manager

Qualifications

• Bachelors Degree Health clinical biological or mathematical sciences or related field.
• 7 years direct Data Management experience including 5 or more years as a CDM project lead. Equivalent combination of education training and experience.
• Previous experience and proven competence in managing delivery of multiple global trials through full DM life cycle (i.e. large trials of at least 1000 patients).
• Demonstrated expert data management skills and advanced knowledge of the data management process (e.g. therapeutic area extensive knowledge in DM processes SAE reconciliation external data vendor reconciliation management of local laboratory data and/or new technology).
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology.
• Pharmacology Anatomy and/or Physiology. Knowledge of operating procedures and work instructions and the ability to apply them in practice. Knowledge of Good Clinical Practices and relevant regulatory guidelines.
• Previous experience and proven competence in managing delivery of multiple global trials through full DM life cycle (i.e. large trials of at least 1000 patients). Demonstrated expert data management skills and advanced knowledge of the data management process (e.g. therapeutic area extensive knowledge in DM processes SAE reconciliation external data vendor reconciliation management of local laboratory data and/or new technology).
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology.
• Soft skills: customer focus manages complexity balances stakeholders directs work plans and aligns communication and negotiation.

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