Principal Clinical Data Analyst

Description:

- Responsibility for internal and outsourced data management activities in support of clinical research studies.

- Leadership of Clinical Data Management study sub-teams. Implements Study Specific procedures compliant with Regulatory and internal procedures and requirements.

- Responsible for the design, documentation, testing, implementation and management of clinical data collection, review, clarification and reporting systems for clinical studies.

- Manages assigned project timelines and prioritization of tasks.

- Organization and coordination of internal and external data management activities supporting clinical trials in one ore more therapeutic area. These responsibilities include supporting and influencing multi-disciplinary Clinical Trial sub-teams to effectively manage information flow, data collection, review and clarification activities according to appropriate regulatory and company and departmental guidelines.

- Responsible for supporting the documentation, testing, implementation, validation and utilization of systems and processes within the Clinical Data Management area.

- Implements data management procedures compliant with Regulatory requirements. Ensures the consistent implementation of procedures, data standards and data coding dictionaries across assigned studies within therapeutic areas.

- Collaborates with internal and external resources (CROs) to ensure consistency of methods, interpretation and approach.

- Manage Contract Research Organizations (CROs) and service providers' activities for outsourced Clinical Trial services. Coordinate internal resources and activities to facilitate timely collaboration with external vendors.

- Support the development and training of Clinical Data Management personnel.

- Contribute to the processes for the standardizing of data collection tools, formats and associated documentation (CRFs, e-CRFs, IVRS, hand-held diaries, etc.).

- Collaborate with others within the department in the review and evaluation of process improvements based on improved operations, methods, or technology implementation.

Requirements:

- Degree and experience in Computer Science, Life Sciences or related fields.

- Four to Six (4-6) years of relevant pharmaceutical development experience with a Bachelor's degree or equivalent. Two to Four (2-4) years of relevant pharmaceutical development experience with a Master's degree or equivalent.

- Two to Four (2-4) years of leadership role in a Clinical Data Management environment.

- Minimum of one (1) year in a project management and leadership position with timeline and budgetary responsibilities.

- Experience in a medium to large pharmaceutical company or Contract Research Organization setting

- Project Management experience in a clinical data management environment

- Experience in the implementation of global standards related to clinical study data management activities (CRF design, data standards, data dictionaries, coding and coding dictionaries, etc.)

- Excellent knowledge of clinical data management methodologies as well as current and emerging global data management standards.

- Knowledge and understanding of Regulatory Guidelines for the use of computer systems in clinical studies.

- Technical abilities and skills in the use and management of computer databases. Programming experience helpful.

- Demonstrated Leadership, analytical, and problem solving skills.

- Excellent organizational, verbal, written and inter-personal skills.

- Ability to work on a multi-disciplinary team with multiple priorities.

- Excellent project management and prioritization.

- Ability to travel 10-15%.