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.
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 firstname.lastname@example.org
Life Science degree
5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business