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Senior Clinical Project Manager

Exciting opportunity in an international pharmaceutical company, where you can make a difference

 

As Senior Project Manager at ALK, you will join the Clinical Project Management team consisting of 15 dedicated employees.

You will be responsible for leading the operational and oversight activities for global clinical projects throughout the planning, conduct, and reporting phase.

With direct report to Head of Clinical Project Management.

Your main tasks are:

  • Within the frames of the project plan, to prepare trial plan/timelines and communicate this to the trial team and other relevant parties
  • To give input to and review Trial Outline and Clinical Development Plan (CDP) and write the clinical trial protocol together with important stakeholders
  • To coordinate and drive the clinical trial submission process to relevant regulatory authorities, ethics committees, data protection authorities, etc. in accordance with local rules and regulations (ensure oversight if task is outsourced to CRO)
  • To organise CRA and/or investigator meeting (in collaboration with CRO)
  • In collaboration with the Outsourcing Manager, to participate in Bid defense meetings and CRO selection process
  • To coordinate and ensure progress in site budget and contracts in due time for site initiation
  • In agreement with the trial team, to set trial related goals and monitor the progress against the plan
  • Ensure oversight of all trial related activities and documentation thereof together with CRO
  • To review and approve the trial specific procedures and documentation
  • Act as the link to the CRO and assure that the CRO is working according to the agreed terms and conditions
  • To establish clear communication lines and information within the trial and clinical teams as well as with line management
  • To coordinate trial plans, resource needs, etc. with line management as well as to ensure that line management is informed about issues and actions that could have any impact on quality and/or timelines

Your qualifications are a minimum of 5 years’ experience in clinical trial conduct from either a headquarter or a biotech company. Further, you must possess thorough theoretical and practical knowledge of GCP and clinical trials. You are used to managing clinical projects and having the overview while also acting operational. You are skilled in oral and written communication, and you are used to creating long-lasting collaborations with both internal and external stakeholders, e.g., CROs. Finally, it is crucial that you possess scientific knowledge.

You have a relevant scientific education.

You are a person with a proactive mindset, and you take ownership of your assignments. You are solution-oriented, pragmatic, and flexible. You are curious and ask questions and can be both detail-oriented while having an overview. You have the ability to navigate in an evolving environment, where all processes, roles, and responsibilities are not necessarily pre-defined. Finally, you are team-oriented and open-minded.

ALK offers an exciting position, and as ALK is experiencing growth and with a developing pipeline, there will be room for both professional and personal growth.

Travelling: Approx. 10 days per year.

Domicile: ALK’s office in Hørsholm.

For more details about the job or the company, please contact Senior Consultant Belinda Bramsnæs, Unique Human Capital on M: +45 28 44 28 44 or Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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