Clinical Trial Leader

Beschreibung

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:

Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main focus will be de- pendent on department workload and need). Responsible for leading and matrix managing the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
CTL role will involve the following tasks.

? Author of the clinical study protocol and other study essential documents.
? Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.
? In collaboration with outsourcing/planning/feasibility personnel, CTT, Local CPO representatives and CRAs, identify sites and manage study set-up, 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), and coordinate the data analy- sis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations. May support the Medical Expert on project documentation e.g. Briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.
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(s), ensuring clear delegation / assignment of duties are
documented.
Contribute to the identification and evaluation of new clinical sites as appropriate for assigned
studies.
Provide CS&I expert advice to other departments and line functions (e.g. CQA, Drug Metabolism
and Pharmacokinetics (DMPK), Drug Supply Management (DSM) as applicable to assigned studies.
Maintenance of knowledge and training of ICH-GCP, current regulations and procedures.



Ideal Background:

Education:
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 requirements:

Relevant experience (5+ years) in clinical trial management (e.g. study management in a multi- national environment using different models for trial execution).
Demonstrated leadership and problem-solving skills.
Track record of managing multiple, complex clin- ical trials.
Capable of clear written and verbal expression of ideas, an active/proactive communicator.
Ability to interact with a wide range of people and build strong positive relationships.
Potential for customer orientation awareness and focus.
Computer literacy.
Excellent organizational skills and interpersonal skills.
Ability to work independently and in a team environment managing multiple priorities