Director, Clinical Data Management (US)
Location: United States
Requisition Number: 2367
Position Title: Director, Data Management
The Director Clinical, Data Management will provide leadership, managerial and technical expertise to the Data Management Department, working in operational framework to ensure efficient, accurate and timely completion of Data Management Deliverables.
Tasks may include but are not limited to:
- Lead and manage staff performing Data Management and Database Programming activities.
- Responsible for allocating assigned staff, ensuring appropriate staffing and delegation.
- Recruit staff
- Identify group’s training requirements, provide training as and when required.
- Develop staff member including performance of staff appraisals and continued management.
- Contribute to the strategic management of the department. Liaise with others to coordinate project specific development activities.
- Design solutions to enable Data Management, and to ensure related clinical trial management and clinical data requirements are met
- Lead the development and implementation of new processes and/or technologies enabling Data Management
- Develop and implement Quality Management Documents and other procedural documentation.
- Ensure that all operations carried out by department are conducted to applicable regulations, GCP, Worldwide QMDs and guidelines, and to the requirements of the sponsor
- Ensure solution specifications are agreed with applicable sponsors and internal colleagues.
- Ensure self and team liaise with technology and other scientific/medical colleagues.
- Ensure database specifications, data collection interfaces and data reporting tools are developed.
- Represent company at meetings with sponsors and vendors.
- Assist Business Development and company management by reviewing and providing input to project proposals. Participate in bid defense meetings and presentations to sponsors as required.
- Plan, monitor project progress, assess work against contract, identify and report out of scope work and assist with costs estimates for proposals as well as change orders.
- Monitor and assist with financial forecast for the Department, working with Finance to identify revenue anomalies
- Monitor and address as necessary system and application performance
- Participate in internal audits as well as inspections and audits by third parties. Ensure that recommendations are addressed and applicable actions follow-up to completion.
OTHER SKILLS AND ABILITIES:
- A good standard of written and spoken English
- Excellent time management skills with ability to work to and direct project plans
- Ability to prioritize and handle multiple projects simultaneously; flexible and able to use sound independent judgment and take initiative to assess information
- Proven leadership and management skills
- Excellent working knowledge of Data Management Systems and principles
- Educated to degree level or with at least 10 years relevant Clinical Data Management experience.
- Clinical drug development experience including experience in software or application development and deployment.
- Excellent written and verbal communication skills and strong attention to detail are essential.
- Proven ability to design and/or develop Data Management solutions deployed in clinical trials.
- Good knowledge of guidelines and regulations relevant to the deployment of technologies and programming in clinical development programs.
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Director, Clinical Data Management (US)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Research Triangle Park, North Carolina US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.