Beschreibung
Workload: 100%Start: Asap
Duration: 18 months
Job Purpose:
Responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Functions as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures).
Major Accountabilities
• Author of the clinical study protocol, amendments and related documents. Informed Consent Form, monitoring plan and other study essential docu-ments.
• Responsible for ordering and management of clinical trial materials, includ-ing drug supplies and CRFs.
• Leading all aspects of study planning andiIn collaboration with outsourcing/ feasibility personnel, CTT members, Local Country Office representatives and CRAs, identify sites and manage study set-up, including responsibility for or-ganizing 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 ques-tions and serve as point of contact for managing/answering questions relat-ing to trial procedures and subjects’ eligibility.
• Ensure the set up and maintenance of the Trial Master File for assigned stud-ies, 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 writ-ing/narrative group to ensure report is completed according to current re-quirement. Responsible for report publication.
Ideal Background
Education (minimum/desirable):
BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD or equivalent qualification or work experience.
Languages:
Fluent written and oral English
Experience/Professional Requirement:
1. At least 5 years relevant experience in clinical trials / drug development (e.g. study manage-ment in a multinational environment using differ-ent models for trial execution).
2. Demonstrated leadership and problem-solving skills.
3. Track record of successfully managing multiple, concurrent phase I and IIa complex clinical trials.
4. Strong operational project management experi-ence including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
5. Capable of clear written and verbal expression of ideas, an active/proactive communicator.
6. Well-developed interpersonal skills, with a proven track record of successfully interacting with and influencing a wide range of people building strong positive relationships.
7. High level of customer orientation awareness and focus.
8. Office and clinical trial software IT computer lit-eracy.
9. Excellent organizational skills and interpersonal skills.
10. Used to and ability to work independently and in a team environment managing multiple priorities
11. Being flexible and adapting in a changing environment.