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/programme of global studies Provide leadership and senior support to DTLs on multiple large global studies/programme of 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, e.g., 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

Ensure appropriate resources are assigned to meet project deliverables

Create and/or review and sign-off 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

Continuously look for opportunities to improve service

Develop and work with team to implement plan to re-organise and drive change (possibly across a customer account)

Ensure timely follow-up and resolution of compliance issues

Serve as Subject Matter Expert (SME)

Provide leadership and expertise in a specific CDM task or technology

Serve as customer site lead for one or more customers

Train and mentor junior DTL staff in DM expertise

May coordinate the work of more junior DTL staff

Independently maintain internal tracking databases and systems

Financial Management/Business Development Support:

Independently manage SOW/budget

Review financial reports on a monthly basis and participate in project reviews as requested

Identify out of scope tasks and track change orders to completion

Participate in pricing discussions across customer account

Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing

Independently support RFP process (review RFP documents, pricing, attend bid defense) Other:

Independently bring process improvements and solutions to the CDM team/CDM department

Lead a focus team or global or local best practice team

Communicate lessons learned and/or present in CDM workshop(s)

Manage the development and implementation of new technology or tool

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

Bachelor's Degree Health, clinical, biological or mathematical sciences, or related field Req

5 years of direct Data Management experience with 3 or more years as a CDM project lead Pref

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. Excellent communication, interpersonal, customer service, and teamwork skills.

Excellent organizational and problem-solving skills. Excellent project management skills.

Ability to work independently. Comprehensive understanding of clinical drug development process.

Ability to establish and maintain effective working relationships with coworkers, managers and customers.