Senior Trial Data Manager
Serve as point of contact and manage delivery of sponsor in-house projects within the FSP contract through full Data Management scope per agreed upon timelines, resource needs, best practices and with quality per FSP guidance and requirements.
Manage full life cycle of Data Management deliverables including CRF/e-CRF, database design and set-up, user acceptance testing (for trials in start-up and post-production changes for trials in conduct) and programming specifications, Data Management Plans, and database deliverables where applicable (excluding ALL project financial tasks).
Conduct comprehensive data management tasks including but not limited to data reconciliation, metric reporting, data review, writing and resolving data clarifications.
Establish strong communication with DM Support, Clinical Trial Lead (CTL), all core and extended CTT team members and functional leads as necessary to ensure all milestones/deliverables are met.
Manage process improvements and workload projections by provide LEAN/technical advice to solve problems and improve efficiency within the FSP and help others through the learning curve to achieve trial goals with subsequent implementation.
Provide comprehensive technical expertise to the DM Support, Programmer/Database Developer and Clinical Trail Team (CTT) and interact as need be.
Create and/or review and sign-off on all FSP data management plans and other relevant trial documents.
Serve as the escalation point for unresolved data issues working with CTL, DM support, vendors, and CTT as needed to ensure root cause identification, timely follow-up, and implementation of remedial actions/resolution of issues.
Escalate problems/issues to the attention of the PCDM/Engagement Manager and Data Analytics and Review Team (DART).
Comply with all IQVIA Corporate Policies, FSP specific Sponsor Standard Operating Procedures (SOPs)/Working Practices (WPs), FSP curriculum and key performance indicators.
Train, mentor and provide leadership to fellow FSP team associates on data management skills and processes.
Collaborate with TDM(s) to ensure DB start-up activities & Go-Live dates, deliverables and all milestones are met as per agreed upon timelines and per FSP standards.
As a LEAN practitioner and FSP ambassador identify and support initiatives and process improvement strategies that can assist project teams in achieving their goals and set FSP expectations.
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:
Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
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)
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
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 co-workers, managers and customers
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and a minimum of 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience
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