Clinical Trial Leader (m/w/d) 100%

For our client, a renowned pharmaceutical company based in Basel, we are seeking a:

Clinical Trial Leader (w/m/d) 100%

Tasks & Responsibilities:

  • Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main focus will be dependent on department workload and need
  • Responsible for leading and matrix managing the multidisciplinary CTT and support functions
  • ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
  • 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
  • Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions
  • 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
  • Regularly update all trial information databases in order to manage accuracy of information
  • Review and approve all study payments as per financial agreements
  • In collaboration with the Medical Expert and CTT, coordinate the ongoing medical / scientific review of the clinical trial
  • coordinate the data analysis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations
  • 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 (PKS), Drug Supply Management (DSM) as applicable to assigned studies
  • Maintenance of knowledge and training of ICH-GCP, current regulations and procedures

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 clinical 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

General Information:

  • Start date: 09.01.2023
  • Duration: 18 months
  • Workplace: Basel
  • Workload: 100%
  • Home office: only occasionally possible

 

Marilu Mercedes
Marilu Mercedes
Telefon: 058 255 31 04

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