Outsourcing Manager

**Summary / purpose of the position**
This role requires close collaboration with DMPK project representatives, contract management, finance, and procurement. Additionally, the individual must build and maintain strong working relationships with Contract Research Organizations (CROs) worldwide.

**Main responsibilities / job expectations**
Outsourcing Management
- Identify, evaluate, and select appropriate CROs for in vitro ADME and in vivo PK studies
- Design study protocols in collaboration with DMPK project representatives
- Follow up on contracts and ensure PO approval and modifications as needed
- Ensure timely initiation of the study (shipment of materials, etc.)
- Supervise critical phases of the study and ensure timelines are met within project needs
- Serve as point of contact between internal teams and external CROs

Regulatory Compliance
- Ensure the appropriate regulatory compliance is met for the study given the stage of the project
- Maintain records of study conduct, data and communications for future audits
- Ensure in vivo studies are designed to comply with Ipsen’s animal welfare policy

Data Review
- Review study data to ensure appropriate adaptation of the study protocol
- QC data tables and reports
- Review content of draft reports to ensure compliance with study goals

Data Reporting
- Upload discovery data and into database
- Laise with DMPK representative to finalize reports and upload into document management system

**Experience / Qualifications**
- Educational level in DMPK or related field with 2-5 years of experience in CRO or pharmaceutical industry.
- Experience with CRO management is highly desired.
- Operational level of English is required.
- Experience with bioanalysis and immunoanalysis a plus.

**Key Required Technical Competencies**
Strong project management skills
Ability to work in a team within a multidisciplinary environment
Excellent communication and negotiation abilities

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