Priya Mukherjee at CK Clinical is recruiting for a Director of Clinical Data Management to join a leading Pharmaceutical organisation based in South East, UK.
Director of Clinical Data Management Job Description
The purpose of the role is to collaboratively produce and support critical data-based evidence for assertions and label claims about medicines through all Phases (I-IV, NIS, IIT) covering biomarkers, efficacy, safety, PRO/QOL and HEOR HEOR for simple and complicated trial designs and challenging analyses.
As Director of Clinical Data Management, you will handle the day-to-day operational managerial role of single EU Data Management team integrated over UK and Germany delivering a regional tactical focus with strong global liaison on a coordinated joint delivery with other regions – across various therapeutic areas including oncology, cardiovascular, and metabolic. Through strategic leadership in project teams, you will add value to the company by accelerating worldwide product approvals and enhancing EU product market share and appeal. As Director of Clinical Data Management, you will also enhance functional technical expertise in designing, driving and delivering high quality objective core contributions at the heart of the EU drug development and commercialisation process together with the required ‘state-of-the-art’ regional and global infrastructure.
As Director of Clinical Data Management, you will have the following key responsibilities:
- Leads a regional Data Management group who oversees all project related data management activities, including but not limited to developing, directing, prioritizing and monitoring CRF design, data collection, edit checks, consistency of data collection, query management, data quality control, medical coding, SAE reconciliation between clinical trial and drug safety databases, quality audits and evaluations of databases, data review, database locks, and archival of Data Management deliverables and documents. Oversees and monitors project timelines to ensure that established corporate target dates are met.
- Encourages, monitors, and facilitates data management activities and interactions between international sites, towards the development and implementation of global data management and standards. You will also Identify and implement best practices to increase efficiency, quality, and timeliness of data management processes and deliverables. You will establish and generate metric reports for monitoring the progress and performance of projects and processes against internal targets and timelines, and establish the target competency requirements for Data Management staff, for both internal and external sources; together with defining the training plan to achieve those targets.
- Provide expertise to all areas of data management including project teams, functional areas, and management. You will also monitor data management activities to gauge compliance with standard processes, evaluate contracted CROs and external vendors on an ongoing basis for adherence to contract specifications and expectations.
- Evaluate CRO and external vendor candidates as to their ability to perform in accordance to company procedures and quality standards prior to contract finalization. Ensures that the complete archiving of databases, Data Management documents, and records is maintained in accordance with applicable company and regulatory guidelines.
- Provides leadership to Data Management in setting short-term and long-term departmental, project, and professional goals and objectives. Create momentum, energy, and opportunities for visibility of group within corporate and functional settings. Expand support to new areas and build new cross-functional relationships while solidifying and enhancing existing relationships.
Qualifications, skills and experience:
The successful candidate for this Director of Clinical Data Management position, you will have the following qualifications, skills and experience:
- MS; BS/RN in life sciences (OR Equivalent)
- Proven pharmaceutical experience, including data management, clinical trials, and drug development; Proven supervisory/management experience and project management experience, with exposure to vendor risk and performance management, compliance and oversight.
- Good oral and written communication skills.
- Proficient in Microsoft Office Suite including Word, Excel, and Project
- Demonstrated problem solving, analytical, organization, and time management skills
- Excellent managerial skills; coaches, guides, and professionally develops direct reports
- Exhibits customer focus, flexibility and team spirit
- Ability to lead and influence others
- Demonstrated experience in leading remote teams
- Ability to function effectively in different cultural settings
- Proven experience in the implementation of electronic data capture (EDC)
How to apply:
For more information regarding this Director of Clinical Data Management position, please contact Priya Mukherjee at CK Clinical on +44(0)1438 870028 or email firstname.lastname@example.org. Please quote reference CL24295 in all correspondence.
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