Principal Clinical Data Manager APM8942719 (DT)
No Corp to Corp
- Experience in vendor management of outsourced studies.
- Possess management experience; training and development of personnel; and preparation and conducting performance review
- Possess a thorough knowledge of medical terminology; and the clinical data management and the clinical trial pro
- Proficient on regulatory requirements for data management and the regulatory submission pro
- Experience in developing SOP
- Proficient on the design and validation of data collection instruments; the data collection and data review process; and data standardization.
- Experience with CDASH terminology and/or MedDRA and WhoDrug medical coding required.
- Medidata Rave and CODER experience required.
- Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
- Proficient on evaluating, testing, and managing new data standards, technologies, and system
- Proficient on developing request for proposals for external vendor contra
- Experience in solving complex and increasingly difficult problems, independently taking the appropriate corrective action, and identify and implement improvemen Able to review, interpret and evaluate clinical data.
- Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the compan
- Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneousl
- Able to effectively coordinate personnel, vendors, teams, and proje
- Typically requires a degree (e.g., BS, BA, MS, MA, PhD, PharmaD, or PhD) or professional qualification in a health science field (e.g. nursing, pharmacy) or a relevant scientific/technical discipline with demonstrated experience with responsibilities, deliverables, and skills required for this level.
- Significant experience in the pharmaceutical industry is preferred.
- 7+ years with BS/BA
- 5+ years with MS/MA
- 3+ years with MD, PharmaD, or PhD
- Related experience in life sciences or pharmaceutical industry may be equivalent substitution for education
- Competence with MS Office programs, particularly Word, Excel, Project and PowerPoint
- Strong knowledge of current EDC technologies (e.g., Medidata Rave)
- Self-motivated, reliable team member
- Ability to communicate effectively with senior management as well as with peers
- Excellent written and verbal communication skills
- Good planning skills
- Ability to solve problems of challenging nature
- Adherence to timelines
The Senior Manager of Clinical Data Review in the Global Clinical Data Management (GCDM) department is responsible for the development of a clinical data review program and process to ensure the delivery of clinically-sound high quality data on time and within budget scope. This position will also be responsible for developing the key infrastructure required for supporting the clinical data review requirements for Phase I-IV clinical research in collaboration with the coding, medical and safety departments. This position will be responsible for providing support to all medical coding initiatives. The ideal candidate will have experience managing the clinical review of data collected in rare disease trials. This position will be responsible for all aspects of medical coding and clinical data review.
- Manages all operational and administrative aspects of the clinical data review tasks and staff.
- Serves as the leader in developing content and strategy for all clinical data review decisions including the development of standard operating procedures and project specific clinical data review guidelines.
- Ensures that clinical reviews are conducted accurately with consistent outcomes including the management of associated medical coding, safety, and medical guidelines.
- Supports all operational and administrative aspects of the dictionary management and medical coding tasks.
- Supports development of and adheres to the client’s coding conventions.
- Collaborates with Clinical Data Management (CDM) to ensure timely completion of clinical data review tasks including review of clinical data review requirements during development of the following: Case Report Forms (CRF), CRF guidelines, Data Review guidelines, and Data Management Plans.
- For outsourced trials, manages vendor counterparts, with responsibility for performance evaluation to ensure competence in clinical data review skills and knowledge.
- Develops projects and ensures successful completion of all projects related to clinical data review.
- Co-accountable for successful completion of cross-functional projects related to clinical data review processes; may also lead cross-functional teams.
- Ensures development of training programs for end-users as well as staff from other departments on clinical data review conventions and tools.
- Collaborates with the Associate Director, Global Dictionary Management and Medical Coding to assess the MedDRA implementation and WHO Drug implementation impacts on clinical reviews, analysis, and regulatory reports, and proactively addresses the issues with affected groups.
- Viewed as the central point of contact within the organization for clinical data review and related tools and applications.
- Serves as a consultant and external spokesperson for the organization on significant matters relating to policies, programs, capabilities, and long-range goals and objectives.