Eu Director Site Contracts

vor 2 Wochen

Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
**EU Director Site Contracts & Budget Management (M/F/x)**:
This role could be filled either in Germany, UK, France, Spain or Italy

This role is one of the Global Clinical Operations (GCO) function’s key leaders and Subject Matter Experts (SMEs) for clinical site contracts. The role supports global study delivery by providing expert technical input into strategy, process and resource requirements to ensure the timely and efficient execution of site contracts. The EU Director, SCBM provides expertise, guidance, and training and identifies process improvements and implements best practices applicable to the global administration of the site contract process. The role supports and coordinates all process, governance and implementation activities within the site contract’s function.

As a SME for the site contract processes, the role develops portfolio level site contract strategy, oversees the escalation process, identifies process improvements, participates in functional governance activities and CRO relationship management, and liaises with internal/external stakeholders on cross-functional initiatives with particular focus on study start-up.

**The responsibilities include**:

- Determine strategy, process and resource requirements for the site contract process
- Liaise with GCO functions as site contracts SME for ongoing relationship maintenance, initiatives and challenges
- Liaise with DSI Legal, Compliance on Company positions on study specific issues, legal developments and regulatory guidance
- Provide functional input to develop better defined process flows, roles and responsibilities and templates to ensure smooth transitions and handoffs are maintained with rigorous oversight
- Provide guidance and support to the execution function when needed to ensure timely and compliant execution of contracts and contracts amendments
- Ensure site contracting and relationship management/governance are aligned with quality requirements
- Provide Asset/Study level support to Site Contracts teams
- Provide management, training and development of personnel
- Provide resource management through forecasting and work-flow management
- Design, implement and monitor quality oversight plan
- Develop, implement and support site contracting model for emerging markets
- Provide effective CRO performance management and oversight by establishing and monitoring performance and quality metrics
- Develop and implement an effective escalation framework for site contracting and budgets & CRO operational performance
- Recruitment, hiring and management of employee direct reports or contractors as the business requires

**Qualifications**:
**Education**:

- Bachelor’s Degree is required
- Master’s Degree in relevant field would be a plus
- or equivalent combination of education, training and experience that provides the individual with the required knowledge, skills and abilities for the position.

**Experience**:

- Minimum 8-9 years pharmaceutical/biotechnology industry experience
- Demonstrated success in working cross-functionally in a global matrix organization; minimum 8-9 years experience in managing or supporting global cross-functional processes
- Must have previous experience within Clinical Operations and have a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines
- Excellent negotiation skills, conflict resolution, decision making skills, communication (oral and written) and presentation skills
- Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe

**What we offer**:
**Working at Daiichi Sankyo**:
At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.

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