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Associate Study Start-Up Project Manager. Copenhagen, Denmark.

Employer
Labcorp
Location
Copenhagen, Denmark
Salary
Competitive
Start date
3 Mar 2021
Closing date
8 Mar 2021

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


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

This role would suit eitheran 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 beregulatory 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

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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