covance

Associate Study Start-Up Project Manager. Copenhagen, Denmark. (BB-AF17F)

Found in: Neuvoo DK

Description:

Job Overview:

We are looking for a Study Start-Up Project Manager to be office based in Copenhagen, Denmark.

This role would suit either an experienced CRA, perhaps looking for less travel, or an existing Study Start-up specialist looking for a more senior & progressive role.

This particular job will be 100% client dedicated with a global Pharmaceutical company

The main responsibilities will be regulatory tasks (submission to EC, HA and writing ICF) and also budget/finance tasks (contracts and budget).

This position has a significant impact on how Denmark can deliver country-specific trial commitments and objectives, especially during start-up.

Qualifications, Skills and Experience

Core competencies :

  • Expertise of core clinical systems, tools and metrics
  • Excellent English skills
  • Strong coordination and organizational skills
  • skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
  • Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the SCOM
  • Ability to make decisions independently with limited oversight from SCOM
  • Requires strong understanding of local regulatory environment
  • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
  • Behavioural Competency Expectations:

  • Problem solving is essential to this position.
  • Requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
  • Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
  • Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
  • Other Information:

    This role is a full time & permanent position to be employed through Covance. For more information please contact Andy Smith on +44 (0) 7775 848 250 or mail andy.smith@covance.com

    Education/Qualifications:

    Life Science degree

    Experience:

    5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

    calendar_today2 days ago

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