Responsibilities:
1. Ensure successful completion of clinical studies that are on time and within budget. Accountable for ensuring all needed aspects of clinical operations are identified (drug, resources, contracts, budgets, etc) and planned in timely manner. Generate contingency plans where necessary, proactively identify potential issues/risks and mitigate.
2. Manage and monitor performance of all vendors to ensure successful completion of program with regard to timelines and budget.
3. Manage the budget, contract requirements, and performance metrics for the team to ensure that trials/development program plans are on target.
4. Work with DM to develop data capture tools that reflect the requirements of the protocol. Review clinical data and metrics to identify trends.
5. Develop mitigation plans as necessary.
6. Review and approve clinical supply and dispensing design and drug labels.
7. Liaise with study site and Investigational Review Boards (IRBs) and Ethics Committees (ECs) requirements and questions.
8. Review and contribute to key study documents including protocols, case report forms (CRFs) and Informed Consent templates.
Qualification
1. At least 3 years of experience as study manager. Have ability to manage studies in house as well as collaborate with CROs. Biotech plus MNC experience is preferrable.
2. Recent experience of managing hematology and/or lymphoma study as study manager. Experience of global study, early phase study, and first-in-class product study is preferrable.
3. Proved capability in patient recruitment and maintenance.
4. Bachelor’s degree in Life Sciences, Pharmacy or Clinical Medicines. Advanced degree preferred.
5. Excellent written and oral English.
6. High degree of accuracy with attention to details.
7. Fast-adaptor, can work under pressure. Excellent team player.