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.
The Program Clinical Data Manager manages the relationship with key clients. The successful candidate provides leadership, management and technical expertise to team members working on clinical trials. The Program Clinical Data Manager ensures trials are executed in an efficient, accurate and timely manner to the client’s satisfaction. This is a work-from-home position and may be based anywhere in the United States.
Responsibilities:Tasks may include but are not limited to:
Represents Worldwide Clinical Trials at client meetings to advise on all respects of data management
Liaises and collaborate with internal departments working with the same study clients
Takes responsibility for the training, development, and performance of assigned staff
Ensures all data management operations are conducted to SOPs; contributes to the ongoing revision/improvement of these SOPs.
Writes specifications for the set-up and modification of project-specific data entry and consistency checking software for assigned trials.
Produces reports directly from the clinical database or via the appropriate procedure to request a new report from either the Statistics department or IT department as needed
Coordinates aspects of adverse event management and central event adjudication which relate to assigned projects and to write or approve the corresponding Manuals/guidelines.
Participates in sponsor audits, regulatory authority inspections and other third-party meetings; ensures any recommendations are discussed and that solutions are incorporated
Bachelor degree or higher in life science, nursing or another relevant area
10+ years’ experience in data management
A minimum of 5 years in a leadership role
Must have experience in the CRO industry
Ability to travel up to 25% is required
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.