Job Detail

Clinical Project Manager

Inseriert am: 18.11.2020




Headquartered in Lachen near Zurich, Switzerland, the Octapharma Group is a leading company in the worldwide market for therapeutic human proteins. Working at Octapharma means to have an opportunity to contribute to our common goal – developing lifesaving therapies to improve patients’ lives.

 

 

We are seeking

 

A Clinical Project Manager (CPM / Senior CPM) reporting directly to the SVP CRD Haematology at our group headquarters in Lachen and working in close cooperation with other internal departments like International Business Units, Regulatory Affairs, Pharmacovigilance, Marketing and with external opinion leaders.

 

Your main responsibilities and opportunities



  • Planning, implementation and evaluation of global clinical Phase 1-4 GCP studies  

  • Directing activities of team members to ensure compliance with protocols and overall clinical objectives. Providing input to overall clinical development programs with coagulation and critical care products and lead the development of study protocols

  • Evaluate, analyse and interpret clinical data. Preparing study reports, CTDs, summary reports, expert statements, etc. for Competent Authorities

  • Keeping track of study budgets, involvement in vendor oversight

  • Interacting with Independent Data Monitoring and Steering Committees (install, update, present results, etc.)

  • Representing Octapharma`s Clinical Research at meetings with Competent Authorities

  • Contribute to publications and prepare abstracts, posters and/or presentations for national and international congresses

  • Review scientific literature, participate in continuing education activities or attend conferences and seminars to maintain / keep up to date current knowledge of all aspects regarding clinical studies

 

Your profile



  • PhD or MD background

  • Minimum of 5 / 10 years experience in clinical research (as CPM / 10 years for Senior CPM) in a pharmaceutical or biotechnology company

  • Excellent communication skills to be able to effectively convey messages across to both study team members and other external persons like vendors and external consultants

  • Good organizational and leadership skills

  • Ability to pay keen attention to detail at all times and work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects

  • Engaging and convincing personality for team building and in many cases leading a team

  • In depth knowledge of medical terminology, physiology and pathophysiology related to the relevant clinical trial

  • Experience in writing clinical study procedures and other clinical documents

  • Preferably experienced in the field of coagulation and critical care

  • Excellent problem-solving skills with ability to daily resolve trial issues

  • Strong project management skills and planning competencies to set plans and execute on time and within budget

  • Experience managing CROs and outside vendors to plan and execute Phase 1- 4 clinical trials

  • Excellent presentation skills and expertise in stakeholder management

  • Demonstrated ability to collaborate, multi-task and work effectively in a fast-paced matrix environment

  • Fluent in German and English (written and spoken)

  • Willing to travel up to 30%
     

Our offer



  • Working in a motivated team in an international environment

  • Active participation in the design and conduct of global clinical projects

  • Quick decision making and goal oriented environment
     

How to apply

Please e-mail your application in English describing your interest, expected salary and enclosing your CV, references and/or recommendation letters to: 

 

 

 


 


About Octapharma


Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood.


At Octapharma, our passion drives us to provide new health solutions advancing human life. This is our vision. We thrive as an organisation in which people take ownership, have integrity, demonstrate grounded and confident leadership, drive sustainability, and are inspired by and eager to embrace entrepreneurship.


We employ more than 9 300 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas:



  • Haematology (coagulation disorders)

  • Immunotherapy (immune disorders)

  • Critical care (bleeding management and functional volume replacement)


Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, in addition to more than 120 plasma centres across Europe and the US.


For more information visit www.octapharma.com

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