Manage single / multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction.
Provide expert skills as part of a Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs.
Provide leadership to the team in the area of project planning and execution, financial management, communications and milestone tracking.
Viewed as an expert in data management. May perform role of DTL (Data Team Lead) / customer site lead, responsible for managing and delivering programme of studies for a customer.
Serve as customer site lead for multiple large global studies / programme of global studies.
Provide leadership and senior support to DTLs on multiple large global studies / programme of global studies.
Act as the main overall point of contact for internal and external customers for programme / multiple projects.
Manage relationship with a customer on a CDM site level.
Manage delivery of multiple projects / programmes through the full data management study life-cycle independently.
Independent management of programme / project timelines, quality, resources, SOW (scope of work) / budgets.
Lead CDM customer negotiations on complex timeline, budgetary and other issues.
May serve as Project Manager for single service data management projects.
Manage comprehensive data management tasks pertaining to the documented project specifications.
Manage comprehensive quality control procedures.
Provide data management expertise and process improvement to CDM management.
Mentor other team members in training and developing data management expertise.
Independently bring project solutions to the CDM team and the CDM Department.
Manage a focus team or a best practice team.
Manage the development and implementation of new technology / tool.
Present at professional conferences and / or publish articles in professional journals.
Provide CDM with technical expertise.
Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
Meet objectives as assigned.
Develop and maintain good communications and working relationships with CDM and project teams.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Advanced knowledge of the data management process / systems and experience in specialized data management skills
Comprehensive understanding of clinical drug development process
Outstanding communication and organizational skills (detail oriented)
Proven leadership skills
Ability to establish and maintain effective working relationships with co-workers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree, or educational equivalence, in clinical, biological or mathematical sciences, or related field, or nursing qualification : ,7 years’ experience in clinical trials within a similar function, including proven competence in managing delivery of multiple global projects / programs independently through full data management study life-cycle, including large trials >
1000 patients; also including experience in handling complex customer negotiations and bid defence meetings; or equivalent combination of education, training and experience