Would you like to be a key driver in establishing a successful and efficient collaboration with our CROs in phase 1-3 trials? Are you organized and a strong negotiator? Do you have financial understanding/experience with budget negotiations?
Then come and join our Clinical Outsourcing Department and become our new CRO Outsourcing Manager.
As we are expanding our Clinical Outsourcing Department, we are looking for a new Outsourcing Manager. You should have a background of minimum of 3 years relevant experience within Outsourcing Management, Legal Contract Management, Trial Management or Procurement.
As you will be interacting with multiple internal and external colleagues, you must also demonstrate a high level of interpersonal skills and negotiation abilities.
Our newly established Clinical Outsourcing Department consists of 2 engaged and professional colleagues, and we need to expand with one new colleague. We work as one team and value an informal atmosphere with focus on knowledge sharing and excellence.
At Zealand, Clinical Outsourcing Management plays a central role in the CRO selection and collaboration. Together with your colleagues, you will be responsible for supporting the trial teams in the collaborations with our CROs and contribute to a smooth and seamless conduct of our clinical trials. Your main success criteria will be to build strong, trust-based relations with internal stakeholders and with our CROs to the mutual benefit for both parties.
Since regular office presence is required, candidates should be based in either Denmark or Sweden.
Responsibilities
As Outsourcing Manager, you will be responsible for the following:
CRO selection process
- Facilitating the identification, selection and contracting incl. budget negotiation with CROs and GCP vendors
- Compiling and coordinating RFIs and RFPs with input from CTMs, trial teams, QA, Legal Department, and other internal stakeholders
- Coordinating review and evaluation of CRO bids with relevant stakeholders, and facilitation of the CRO selection.
- Plan and execute Bid Defense Meetings
CRO and Stakeholder Management
- In collaboration with relevant stakeholders, keeping oversight of CRO contracts and ensure consistency in e.g. checklists and responsibility splits
- Facilitation and planning of Governance Meetings with CROs and GCP vendors (agenda, minutes, follow up, etc.)
- Facilitate CRO and GCP vendor performance evaluation and lessons learned
- Ensuring that all CRO and GCP-vendor management activities comply with ICH GCP, GxP and other relevant regulatory guidelines
- Negotiating contracts – i.e. CDAs, LoIs, MSAs, WOs, COs, etc. with CROs and GCP-vendors in close cooperation with QA and Legal
- Developing the Clinical Outsourcing department and build templates and toolkits to ensure consistency in vendor selection as well as CRO and Vendor oversight across projects
Candidate profile
- Proactive, trust building attitude, seeking solutions to challenges always keeping quality in mind
- Strong motivation and willingness to support and facilitate tasks as needed
- Understanding of financial management/ budgeting
- Strong communicator and negotiator
- Proficiency in written and spoken English
Bonding to innovate
Our employees are fundamental to our success, and we continue to be able to attract and retain people with vast experience and talent. We have a unique culture, characterized by excellent teamwork and strong engagement across the organization.
Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other.
We bond as a result of our entrepreneurial culture where our people are encouraged to pursue their ideas and turn them into reality. We are curious about each other’s knowledge and expertise.
We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Zealand Pharma is a place where everyone is heard and contributes to the success, we all want to experience.
The Zealand Pharma DNA builds on four values: (1) We are bold, (2) We empower people, (3) We work as one team, and (4) We can be trusted.
Let’s bond and be bold
We offer a combined compensation package which includes a base salary, pension, bonus, and a possibility to join our employee share program. We care about our employees’ well-being and offer health insurance, use of massage, fitness, and a range of social clubs and activities
To find out more about working at Zealand, visit https://www.zealandpharma.com/careers/zealand-as-a-workplace/
Interested? Please apply no later than November 3, 2024, or as soon as possible. The applications will be reviewed as they come in.
For further information, please contact Christina Elmstrøm at celmstrom@zealandpharma.com or 5060 3823.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a Danish biotechnology company on a mission to change lives with next generation peptide medicines. In our effort to reach our goals bonding is at the core of everything we do. Let it be discovering and developing the best new peptide drugs for patients, engaging with partners or connecting with each other. This has led to more than 10 drug candidates invented by Zealand having advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Additionally, the portfolio includes clinical license collaboration with Boehringer Ingelheim and pre-clinical license collaboration with Alexion Pharmaceuticals. Zealand is based in Copenhagen (Søborg), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or bond with us through LinkedIn
