My client is a leading global clinical stage biopharmaceutical and medical device company whose goal is to develop unique therapies that significantly improve treatments for severe and acute conditions. They are currently seeking an Associate Director/Director, Clinical Data Management to join their dynamic team!
Position: Associate Director/Director, Clinical Data Management
Responsible for supervising and coordinating all aspects of data capture and review, and for site inventory management (IRT) systems. Responsibilities will encompass some in-house departmental management responsibilities. This position leads and directs the work of others.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
- May lead and direct the work of others, including performance appraisals and annual reviews.
- Responsible for standardizing data management procedures, such as departmental SOPs.
- Responsible for CRF/eCRF development and approval.
- Responsible for inventory and randomization technology (IRT) development and approval.
- Updates planning documents and reports
- Interacts with others within the department and with Clinical Operations, Clinical Development, Clinical Supplies, and Safety
- Creates/updates data management plans (DMPs), form completion guidelines, edit check specifications, SAE reconciliation process
- Works with statistical programming to develop data check listings
- Responsible for and oversees discrepancy management
- Ensures documents are up to date, including medical coding guidelines, CRF annotation, data specifications, and electronic transfer specifications
- Demonstrates ability to multi-task across more than one study
- Able to problem solve
- Coordinates user acceptance testing (UAT) for EDC systems
- Performs other tasks as assigned by supervisor
CUSTOMERS OR CLIENTS:
- Research and Development affiliated departments within the company.
EDUCATIONAL REQUIREMENTS (degree, license, certification):
- Minimum of BS or Nursing degree; master’s degree a plus
- BS in statistics or biostatistics a plus
YEARS OF EXPERIENCE:
- At least seven years combined experience in this field or equivalent in clinical setting or pharmaceutical or biotech industry
PHYSICAL REQUIREMENTS / WORKING CONDITIONS of POSITION:
Standard office position which may include hours sitting in a workstation; inputting information into a PC and viewing a monitor; carrying and lifting binders and supplies; navigating stairs, answering and transferring telephone calls, etc.
OTHER SKILLS AND ABILITIES:
- Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology.
- Demonstrated ability to manage and direct others.
- Strong analytical skills
- Must have knowledge of a variety of computer software applications , word processing, spreadsheets, and clinical database software (e.g. Medidata RAVE, Bioclinica EDC, MSWord, Excel)
- Knowledge of clinical studies and operations, FDA regulations, and GCPs
- Possess strong problem-solving skills, strong attention to detail and orientation toward careful meticulous work
- Demonstrate ability to adjust to constantly changing priorities
- Be self-motivated with a positive attitude and the ability to work well with others
- Ability to work in a team environment
SARBANES-OXLEY ACT OF 2002
According to the requirements specified by the Sarbanes-Oxley Act of 2002, the incumbent is responsible for the following:
- Responsible for completing the above duties and responsibilities timely and accurately.
- Responsible for completing the above duties and responsibilities in accordance with the internal controls that make up the internal control framework for all Discovery Labs’ business operational, administrative or regulatory processes.
- Responsible for becoming knowledgeable of the internal controls operating within this department and to comply with these control activities by (1) being aware of the key controls, risks and compensating controls in this business area and (2) by identifying and reporting changes in the operating and internal control environment to their supervisor.
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything