Job Description

Job Title: Principal Clinical Data Manager (PCDM) (Cmed CRS)

Reports To: Team Manager

Department: Data Management Operations (DMO)

Core Responsibilities

Provide leadership to subordinates, and professionally manage clinical trial data (Phases I to IV). Act as a consultant on the requirements for specific Sponsors to ensure that the data management is of the highest quality in order that databases can be declared clean and locked according to ICH GCP standards. Responsible for management of Clinical Data Associates I, II and Clinical Data Managers within DMO.

Principal Accountabilities

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


• Assist and act as deputy for Data Management Operations Team Manager


• Participate in the recruitment of staff, specifically Clinical Data Associates I, II and Clinical Data Managers


• Line Manage, coach, develop and provide leadership for Clinical Data Associates I, II and Clinical Data Managers


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


• In conjunction with Data Management Operations Team Manager, ensure all tasks documented in the Sponsor contract are completed on time and be able to monitor the project budget, resource and implement cost control measures as appropriate. Ensure out of scope work is managed effectively. Keep management/senior management informed of all aspects of the project status


• 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


• Participate in, and support 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


• 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 7 or more years experience in drug development. At least 4 years in the discipline of clinical data management and 2-3 years in leading project teams


• Foreign language skills would be advantageous

Attributes

• Excellent organizational, planning and resourcing skills


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


• Excellent investigative and meticulous approach to all activities and tasks


• Good negotiation, decision making and problem solving skills including risk analysis


• Complete transparent approach, clear and precise


• The ability to manage and coordinate staff/teams and delegate tasks


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