Job Description

Job Title: Senior Clinical Data Manager (SCDM) (Cmed CRS)

Reports To: Team Manager

Department: Data Management Operations (DMO)

Core Responsibilities

Provide professional management and coordination of clinical trial data, on both an individual trial and project level (Phases I to IV).  Identify errors and inconsistencies in CRF data and ensure their resolution in order that databases can be declared clean and locked according to ICH GCP standards.

Principal Accountabilities

• Perform role of Clinical Data Manager (as outlined in Clinical Data Manager job description)


• Ensure tasks documented in the study contract are completed on time and be able to assist monitoring the project budget and resource


• Respond to requests made by the Sponsor for information or presentations such as workshops and project planning meetings as appropriate


• Communicate effectively with the Sponsor via e-mail, telephone conferences, presentations etc in order to fully manage and lead the project or trial


• Train, coach and mentor Clinical Data Associates I/II and Clinical Data Managers. Conduct departmental training workshops or presentations as required


• Participate in, and support and Business Development activities, i.e. bid defence meetings etc


• Actively promote and represent Cmed via attendance at meetings and conferences and as appropriate, become a member/involved with professional associations


• Improve effectiveness of the organisation such as developing new processes, systems and Sponsor relations


• Assist and act as deputy for Principal Clinical Data Manager or Data Management Operations Team Manager as appropriate


• Ensure relevant Sponsor and / or Cmed CRS Working Practices or Standard Operating Procedures are adhered to


• Ensure timely and accurate entry of relevant study information and time recording occurs in the Management Information System (MIS)


• Other tasks as assigned by Team Manager.

Essential Work Experience and Qualifications

• Degree in life sciences, pharmacy, nursing or nursing qualification (e.g. RGN) or equivalent relevant experience


• Typically 4 or more years experience in drug development, at least 2/3 years in the discipline of data management


• Foreign language skills would be advantageous.

Attributes

• Very good organisational skills, plus an understanding of resource & budgeting


• Very good interpersonal and communication skills and the ability to operate effectively in a global working environment


• Work calmly under pressure and meet deadlines


• Professional, positive, dynamic and driven


• Thorough understanding of medical terminology, clinical trial methodology and ICH/GCP


• Thorough level of understanding of physiology, pharmacology, clinical study objectives and the drug development process


• A very good investigative and meticulous approach to all activities and tasks


• Good negotiation and problem solving skills


• Transparent approach, clear and precise


• Demonstrate leadership by the ability to coordinate teams and delegate tasks to meet deadlines


• The ability to work effectively and efficiently with internal partners within Cmed