Clinical Trial Head (m/f)

in Basel region  ‐ Onsite
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Keywords

Description

Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.


We are looking for a
Clinical Trial Head (m/f)

Referenz: -en
Beginn: asap
Dauer: 6 MM
Ort: in Basel region
Branche: Sonstige Überlassung von Arbeitskräften

Ihre Aufgaben:
  • Accountable for the writing of the clinical protocols and related documents in collaboration with the medical director, program section leader or medical science expert: translate the approved trial concept into a quality executable protocol, lead the clinical trial protocol development process, including obtaining CSU/FSRC approval; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Advisors of the major client local medical organizations to ensure country feedback is adequately integrated into protocol
  • Manage all aspects of clinical trials
  • Participate in development of effective working relationship with key investigators to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Lead investigator meetings. Lead protocol training meetings
  • Lead and matrix manage the global multidisciplinary clinical trial team (CTT) to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures from study start up through reporting phases
  • Report study progress and issues with their resolution plan to Global Clinical Teams
  • Lead trial level interactions with Global Clinical Development Operations and other relevant function
  • Lead the clinical trial data ongoing scientific/medical review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations
  • Develop clinical outsourcing specifications to facilitate bid templates and selection of CRO´s
  • Deliver a realistic clinical trial operational plan to the Operational team
  • Forecast trial resources needs accurately for strategic planning
  • Accountable for accuracy of trial information in all trial databases and tracking systems. Assess resource needs with program and management to ensure appropriate line function allocation. Foresee resource gaps, forecast needs and escalate in a timely fashion. Foresee potential risks and develop and execute an operational risk management plan
  • Assign short to mid-term responsibilities to CM who assists in the planning, conduct and reporting of clinical trials. Independently manage the day-to-day interactions with the CMs; provide input to performance evaluations and promotion recommendations of the CMs. Direct talent and career development of direct reports
  • Contribute to program level documents and operational structure, including the development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, and responses to Health Authorities questions
  • Contribute to program strategy. Accountable that program specific standards (e.g., CRFs, outsourcing specifications, data monitoring and validation plans) are developed and applied across all trials to ensure consistency of clinical dossier


Ihre Qualifikation
  • Advanced degree or equivalent education/degree in life sciences/healthcare is required. A Bachelor degree (or equivalent education/degree) coupled with demonstrated experience in pharmaceutical clinical research may substitute for an advance degree
  • Fluent English (oral and written)
  • Experience in technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or CRO
  • Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote)
  • Experience in developing effective relationships with key investigators. Ability to stay abreast of industry trends through networking and self-directed learning
  • Thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and clinical development process
  • Proven ability to assess individual performance capabilities, building on strengths and overcoming weaknesses, to optimize team efficiency in achieving goals
  • Demonstrated excellence and reproducible results in clinical operations, including prioritization of critical path activities and franchise objectives
  • Ability to develop a communication plan within a trial or program, and to communicate in a clear, accurate, and concise manner
  • Please send you CV by Tuesday 17th January 2012



Skills:
- Clinical Project Management
Start date
ASAP
Duration
6 MM
From
Hays AG
Published at
13.01.2012
Contact person:
Jennifer Knebes
Project ID:
297015
Contract type
Freelance
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