Would you like to use your Project Management experience as Senior Project Manager (sPM) in a dynamic and experienced team within Clinical Operations Solutions?
The people our client wants to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. They can offer a highly flexible, free, and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.
NQR is looking for a new colleague to become part of our client’s highly experienced Clinical Operations Solutions Team, where you will be reporting to the Director of Clinical Operations.
You will be responsible for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed quality, budget and timelines on projects conducted by KLIFO. The sPM may take a main role in larger programs and can also have a mentor role for other employees within the Clinical Operations group.
- Main point of contact to sponsor representative
- Lead the clinical trial team and coordinate and manage all activities related to clinical trials through the clinical trial team
- Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
- Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
- Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
- Development of project plans for the conduct of the clinical trial
- Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team
- Facilitator in start-up of trials to other clinical teams, including facilitating of the RBQM process across trials to ensure process alignment in KLIFO
- Mentor for other non-senior employees within the group
- Explain and demonstrate job related tasks during client meetings
- Providing advice to clients within the areas of responsibility
- May participate in global development teams on compound level giving input to clinical development plans and operational strategies across a clinical program
- When outsourced to a client and acting as Sponsor PM:
- Carry out the CRO selection process and review CRO contracts with respects to tasks, budget and timelines
- Lead the Sponsor oversight activities and ensure clear responsibility split between sponsor and CRO
- Develop and review of SOPs to support department activities
- BSc/MSc in the life sciences field or related discipline and a minimum of 7 years in a similar position in the pharmaceutical industry/CRO
- Extensive experience within clinical trial management and understanding the principles of clinical drug development
- Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
- Experience with multi-country and multi-centre studies
- Ability to translate client’s needs into a solid project plan
- Ability to work independently without supervision of a colleague within the group
- Ability to supervise and coach non-senior personnel within the group
- Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
- Microsoft Office skills
Your personal skills:
- Drive for results
- Strategic agility
- Negotiation skills
- Building effective teams
- Dealing with ambiguity
- Strong ability to make decisions
- Problem solving
- Overall overview and analytical capabilities
- Strong planning and task management skills
The company has offices in both Denmark, Sweden, Germany and the Netherlands. You can be working from Denmark, Sweden, or Germany.
The company offers you:
- To work within different therapeutic areas and with tasks of varying complexity
- A heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
- To build international client-relations
- To use and elaborate your competences and experience
- To work in an interactive, flexible, and positive working environment
- Attractive employment terms
Please apply as soon as possible. Interviews will be held on an ongoing basis. Desired starting date is November 1st, 2022, but we are waiting for the right candidate.
Apply through this link: https://app.elvium.com/en/positions/18719/c/applications/new