Beschreibung
+++ Clinical Trial Leader (m/f/d) +++ asap – worload 80 – 100% +++ remote-----------------------------------------------------------------------------------------
Clinical Trial Leader
Location remote
Start asap
End 30.12.2022
Total hours: 3040
workload 80 – 100%
Tasks & Responsibilities
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.
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Must Haves
BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background; PharmD or equivalent qualification or work experience.
• Fluent written and oral English
• 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.
Deadline 28.05.2021 08:00 Uhr
We are looking forward to receive your application (Word file is highly appreciated).
Please send your CV / profile and your rate to:
Don’t hesitate and call in case you have any question regarding the job offer.
Tel. // Jan Noack
Mit freundlichen Grüßen
Jan Noack
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iSAX GmbH & Co. KG
Weinbergstraße 15
01129 Dresden
Tel.:
Fax:
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Seit 1998 bieten wir zuverlässig und kompetent Dienstleistungen im IT-Bereich und verfügt über qualifizierte und motivierte Mitarbeiter. Für namhafte Unternehmen wird ein breites Spektrum von IT-Dienstleistungen im IT-Betrieb, in der individuellen Anwendungsentwicklung sowie im Projektmanagement erbracht.