- Function as Clinical Trial Leader for assigned phase I/II studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main fo-cus will be dependent on department workload and need).
- Responsible for leading and matrix managing the multidisciplinary Clinical Trial Team (CTT) and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices. Communicate study progress to CTT, CS&I Management, TA Heads and project team members. CTL role will involve the following tasks.
- Author of the clinical study protocol, amendments and related documents. Informed Consent Form, monitoring plan and other study essential documents.
- Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.
- Lead all aspects of study planning andiIn collaboration with outsourcing/ feasibility personnel, CTT members, Local Country Office representatives and CRAs, identify sites and manage study setup, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meeting(s).
- Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.
- Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.
- Chair CTT meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to CTT, CS&I Management, CS&I TA Head and Project team representatives and others (as appropriate).
- Regularly update all trial information databases in order to manage accuracy of information.
- Review and approve all study payments as per financial agreements.
- Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.
- Assist in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high quality data are transferred/available in a timely manner.
- Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure report is completed according to current requirement. Responsible for report publication.
- In collaboration with the Medical Expert and CTT, coordinate the ongoing medical / scientific review of the clinical trial data (as needed) coordinate the data analysis and interpretation including the development of first interpretable results.
- Ensure a complete review is conducted of all study documentation within the assigned studies / project at the end of each study, with all essential documents appropriately archived and paper Trial Master Files physically transferred to the central archive.
- Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.
- Oversee the work of assigned support CTL/CTA(s), ensuring clear delegation / assignment of duties are documented.
- Contribute to the identification and evaluation of clinical sites and external service providers as appropriate for assigned studies.
- Provide advice to other departments and line functions and to cross-functional working groups as required as applicable to assigned studies.
- Maintenance of knowledge and training of ICH-GCP, current regulations and procedures and supplement by training and practice of internal policies.
- Responsible for following best practices and standards for trial management within TM; expected to share lessons learned.
Key Performance Indicators
- Management of assigned studies according to timelines, budget and with high quality, ensuring adherence to international and local regulations.
- Effective risk management in trial design and operational planning.
- Contribution towards objectives set for the department.
- Feedback of external and internal customers.
Number of associates
No direct reports. Matrix management of CTT members; 3-5 cross-functional members from TM and other line-functions per study as part of the core CTT. Functions with very limited oversight / management with full accountability and leadership.
Financial responsibility:(Budget, Cost, Sales, etc.)
Responsibility within scope of designated authority: e.g. Authorize study payments according to financial contracts.
Impact on the organisation
Internal impact: Responsible for the availability of high quality, Translational Medicine data according to agreed timelines and budget to enable no delays in decision making and drug registration.
BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD or equivalent qualification or work experience.
- At least 5 years relevant experience in clinical trials / drug development (e.g. study management in a multinational environment using different models for trial execution).
- Demonstrated leadership and problem-solving skills.
- Track record of successfully managing multiple, concurrent phase I and IIa complex clinical trials.
- Strong operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
- Capable of clear written and verbal expression of ideas, an active/proactive communicator.
- Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing a wide range of people building strong positive relationships.
- High level of customer orientation awareness and focus.
- Office and clinical trial software IT computer literacy.
- Excellent organizational skills and interpersonal skills.
- Used to and ability to work independently and in a team environment managing multiple priorities.
- Being flexible and adapting in a changing environment.