Manager, Clinical Development

Principle Responsibilities

• Manage all aspects for company sponsored and investigator-initiated studies (IISs) according to the applicable company Standard Operating Procedures (SOPs) and ensure all managed processes are compliant with internal SOPs and external regulations.
• Ensure that assigned clinical research projects comply with the clinical protocol, the most recent requirements for Good Clinical Practice (GCP) and other applicable regulations.
• Supervise outsourced tasks and services and manage contractor relationships ensuring appropriate oversight of vendors is maintained.
• Drafting any necessary study documents such as synopsis, study protocols, informed consents and study plans as per company SOP’s.
• Prepare clinical study budget and manage clinical study to approved budget.
• Ensure that regulatory documents are obtained from study sites and that study files are set up and maintained in accordance with GCP and relevant SOPs.
• Update and Draft SOP’s as and when required.
• Work with legal and sites to negotiate contracts for IIS’s.
• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
• Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BTG values.
• Carry out other reasonable additional tasks as required by the Line Manager to support the clinical functions.

Education and Experience

University degree in a health-related field with a minimum of three (3) years direct clinical trial experience in a CRO or research-related organization. Previous experience with in-vitro diagnostic studies would be beneficial. EU experience would be beneficial.

Skills and Attributes

• Ability to work confidently work independently and as part of a team.
• Knowledge of clinical research process from Phase I through regulatory submission.
• Strong communication skills (verbal and written) to express complex ideas.
• Experience in contract/timeline management preferred with excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to manage multiple priorities within various clinical trials.
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings.
• Ability to set baseline targets, track trends and implement mitigation plans.
• Understanding of basic data processing functions, including electronic data capture.
• Working knowledge of current ICH GCP guidelines.