Clinical Trial Manager 80 - 100% (f/m/d)

☞ HEMEX AG

Vue: 153

Jour de mise à jour: 29-03-2024

Localisation: Liestal Basel-Landschaft BL

Catégorie: IT - Matériel / Réseaux Informatique

Industrie:

Type d’emploi: Temps de travail : 80-100%

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le contenu du travail

HEMEX AG is committed to changing the future of healthcare by guiding the most promising European start-ups through each and every step to bring innovative pharmaceuticals, medical devices and in vitro diagnostics to the market.

Our Clinical Operations team in Liestal (Switzerland) is currently looking for a Clinical Trial Manager (f/m/d)

Tasks

The CTM is responsible for the delivery of all clinical aspects of the study. Key
accountabilities include assuring the successful conduct of clinical studies
consistent with applicable regulations, guidelines and procedures, as well as
supporting clinical project timelines, contracts, budgets, vendor management,
invoicing, accruals, oversight monitoring visits, meeting milestones and
deliverables, and internal/external communications. The CTM will provide
clinical study support to the Clinical Research Associates for one or more
clinical studies, ensuring efficient delivery of clinical trials.

  • Plan, organize and manage multicenter, multinational clinical trials, conduct phase I-IV trials according to protocol.
  • Manage the development of the clinical protocol and related study-related documents. Write clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, and responses to Health Authorities’ questions.
  • Lead cross-functional, multinational study teams.
  • Establish working relationships with key opinion leaders (KOLs) to optimize clinical
study design, execution, reporting, and publication.
  • Lead investigators’ meetings and protocol training meetings with internal staff.
  • Overall responsibility for all internal clinical meetings related to clinical trials.
  • Report to internal and external stakeholders on study progress and issues, independently provide resolution plan.
  • Overall responsibility for timelines, budget, and resource requirements.
  • Liaise with Medical Safety and test item logistics management.
  • Liaise with Data Management/Biostatistics/Medical writing to analyze clinical trial
data, conduct medical/scientific review, final analysis, and interpretation,
including developing clinical trial reports, publications, and
internal/external presentations.
  • Forecast trial resources and provide budget and quoting/invoicing input to the sales department.
  • Collaborate with external vendors and other 3rd parties, including central lab and imaging vendors.
Requirements

  • A minimum of 5 years of clinical trial experience of which at least 2 years as a CTM
within a CRO or pharmaceutical company.
  • Experience working across multiple therapeutic pharmaceutical areas, including oncology.
  • Experience in Phase 1, 2 and 3 studies and international studies.
  • Efficient working style and hands-on “start-up” mentality.
  • Strong time management, organizational and communication skills.
  • Computer skills including proficiency in Microsoft Office suite: Word, Excel, and
PowerPoint.
  • Strong interpersonal skills, and ability to communicate effectively internally and
externally. Maturity to support junior colleagues in their professional
development. Ability to lead cross-functional teams, influence and motivate
others, diplomacy, and negotiation skills.
  • Have a complete understanding of Serious Adverse Event (SAE) reporting, narratives,
and follow up of SAEs. Excellent knowledge of international standards
(ICH-GCP/ISO, FDA, EMEA).
  • Positive and energetic attitude, customer service oriented. Willing to take the
initiative in a dynamic environment. Ability to work independently and as a
team member.
  • Based in Northwestern Switzerland region.
  • A Master’s or Bachelor’s Degree in a scientific or healthcare discipline is required.
Therapeutic knowledge is a plus.
  • Fluent in English (oral, written) plus at least 1 Swiss national language (German,
French, Italian), any additional languages are a plus.

Benefits

HEMEX is an equal opportunity employer. All employment is decided on the basis of
qualifications, merit and business need. We are committed to providing a truly
diverse and inclusive workplace that supports, inspires and respects all individuals.

  • Join a highly motivated and skilled team working on a variety of medical innovations
  • Office-based employment in Liestal (Switzerland)
  • Pleasant working environment in a dynamic organization
  • Advantageous social security benefits
  • 5 weeks holidays
If you meet the described profile, we look forward to receiving your CV
in English, including supporting documents

We only accept direct applications of qualified candidates. Requests from
headhunters and job agencies will not be answered.
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Date limite: 13-05-2024

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