Provide expertise in overall clinical trial management for the operation team to deliver high quality clinical studies in time and on budget.
Adhere to the master plan of TM/CP studies for Early Drug Development in terms of timelines and budget by collaborating with project team representatives and EDD management. Ensure appropriate resource assignment.
Track progress of all assigned programs, studies, and deliverables in terms of timeline and budget.
Identify potential critical issues related with any aspects of clinical trial management, bring issues to the attention of the appropriate parties, and resolve them proactively.
Work with Outsourcing group to negotiate and manage clinical study contracts/contractor agreements, ensuring the vendors meet their contractual obligations. Maintain professional relationship with vendors and resolve study-related non-scientific issues.
Assist the ClinPharm/TM head in preparing the annual budget submissions and tracking for the department. Maintain departmental study budget and assure adherence to projected study budget.
Analyze current clinical operation practices, develop and implement business processes and procedures. Ensure regulatory compliance in accordance with regulations, Celgene standards and departmental SOPs.
Work on all aspect of clinical trial management, from the protocol development, coordination with other line functions (e.g. Drug supply management), site selection, initiation, monitoring, close-out, to study report. Ensure the GCP compliance.
Coach and supervise CPS by providing proper training, managing day-to-day activities, evaluating qualification and performance, and providing feedback.
A minimum of 5 years of relevant clinical trial management experience, preferably in human pharmacology and translational medicine, is required.
Demonstrated working knowledge of regulations related to clinical study conduct (GCP) is a must. Knowledge of drug development, clinical research concepts and practices, pharmacodynamics and clinical pharmacokinetics is desired.
Experience in writing or facilitating the development of clinical documents including protocol development and informed consent
Experience in collaborating with cross-functional groups including Pre-clinical, Bioassay, Manufacturing, and Regulatory is required
Prior managerial experience is required. The incumbent must possess excellent planning, organization, communication, and interpersonal skills are required.
The incumbent must possess excellent analytical and problem solving skills.
The incumbent must be computer literate.
The incumbent should have the ability to differentiate critical events at study sites and to communicate effectively these issues to the appropriate parties.
Ability and willingness to work within a matrix environment.
Ability to multi-task and to manage in an environment with shifting priorities