Global Trial Leader/Clinical Trial Head (CTH)

- Lead the development of global clinical protocols. Responsible for authoring and compiling

clinical protocols and related documents (eg informed consent) in collaboration with the
Medical Lead and the Clinical Trial Team. Submit and present clinical trial protocols to internal review board for approval. Responsible to ensure all required documentation is provided to each participating country for HA and/or IRB/IEC submissions. Lead the data review team to ensure the quality of data in the clinical
database.
- Lead the development of medical and scientific trial related documents (eg charters,

scientific training material); build effective relationships with investigators and experts;
organize and participate in study advisory committees (eg Data Monitoring Committee,
Steering Committee); conduct investigator meetings/trainings. - Responsible for operational and functional management of clinical managers (CMs). Establish annual objectives according to Oncology Global Development (OGD
accountable for representation at all internal meetings related to the clinical trial: chair
routine CTT meetings, participate and report study progress and issues/resolution plan at the
International Clinical Team (ICT). Write ICT meeting minutes as applicable. - Accountable for ensuring compliance with company's processes to deliver high quality clinical trials. Responsible for ensuring trial information/results are reported within relevant trial repositories and tracking systems (eg trial results registries).

- In collaboration with internal stakeholders, (eg Global Monitoring Organization (GMO), Drug

Supply Management (DSM) and Outsourcing Management), manage and forecast study
country allocation and recruitment targets, drug supply and comparator drug
products. Ensure ongoing scientific review and validation of clinical data.
- Develop clinical outsourcing specifications to facilitate bid process and selection of Contract

Research Organizations (CROs); manage interface with CROs in cooperation with Outsourcing
Management and line functions; ensure vendors meet quality standards; contribute to the
development/amendment of vendors contracts.
- Develop Case Report Forms (CRFs), edit checks, CRF completion guidelines, data review

reports and trial statistical analysis plan in collaboration with the trial data manager, trial
statistician, statistical programmer and medical lead.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.