NQR is looking for a Senior Project Manager for KLIFO

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.

The position:

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.

Your responsibilities:

• 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
  

Your qualifications:

• 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 

Location:

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

Deadline: 

Please apply as soon as possible. Interviews will be held on an ongoing basis. Desired starting date is November 1^st, 2022, but we are waiting for the right candidate.

Apply through this link: https://app.elvium.com/en/positions/18719/c/applications/new