Manager, Clinical Partnerships Oversight
Il y a 5 mois
**Purpose of the position**
The Clinical Partnerships Oversight Manager is responsible for supporting the management of Ipsen’s relationships with it’s Service Providers (CROs) within Clinical Development. They are a critical player in the Service Provider Governance and Escalation structure, working to support the Clinical Partnerships Oversight Director to implement and monitor partnerships across Therapeutic Areas and global locations to ensure successful clinical trial execution by the Service Providers. The individual serves as a critical liaison with Procurement, Global Medical Affairs, Biometry and other key internal R&D Functions / Expertise Areas with clinical outsourcing and oversight responsibilities.
**Main responsibilities and tasks**
**Oversight Strategy & Governance of Service Providers**
- Supports Clinical Partnerships Oversight Director in working with Clinical Operations, Biometry and other key stakeholders to design and implement the operating model with Strategic Service Providers (SSPs) to support effective collaboration.
- Ensures appropriate Ipsen approved Risk Management Plans and Issue Logs are in place related to SSPs.
- Supports SSP Steering Committees and Operational Committees, including preparation (agenda), meeting organization (both internal only and SSP/ Ipsen meetings), and clear outputs (meeting minutes, action logs) for efficient and appropriate governance.
- Acts as a central pillar of the Governance and Escalation structure, working with stakeholders to ensure issues are resolved and escalated at the appropriate level, and actions are implemented and tracked to resolution.
**Relationship Management of External Partnerships**
- Supports Clinical Partnerships Oversight Director in regular interactions with SSPs, as well as any other Key Service Providers as needed.
- Supports teams to ensure their study level day-to-day interactions with SSPs/Key Service Providers are efficient.
- Supports teams to establish and maintain strong partner-centric relationships with points of contact in partner organizations to understand their business, drivers, offerings, and politics to develop smooth collaboration in the partnership.
- Works with Clinical Partnerships Oversight Director to collect, analyse and provide regular feedback and updates to and from partners and understand any upcoming challenges. Distribute feedback internally as appropriate.
- Ensures appropriate Key Performance Indicators (KPIs) are being tracked through dashboards, monitored and reported as part of internal management reviews and part of Ipsen/SP governance at all levels.
- Identifies and analyses trends and contributes to continuous improvement opportunities on KPI reports submitted to Ipsen by SSPs/Key Providers.
- Trouble-shoots issues relating to SSP partnerships and performance, working closely with Procurement, Legal, Finance, CDO, GMA and other internal R&D Functions.
- Collaborates with Business Process Owners to ensure policy and procedures governing CDO-related Service Provider selection, qualification and oversight are fit for purpose.
**Collaboration with Internal Stakeholders**
- Supports the efficient, safe, ethical and high-quality conduct of clinical trials alongside all other members of CDO. Key stakeholder interactions include but not limited to:
- R&D Procurement Business Partner(s) and Global Clinical Category Manager(s)
- Biometry
- R&D Regulatory
- Global and R&D Quality
- Global Medical Affairs
- R&D Finance Controllers
- R&D Contract Managers and Legal
- Business Ethics and Compliance
- Takes part in related improvement initiatives as part of the Clinical Trial Excellence (CTE) program, in discussion and agreement with Clinical Partnerships Oversight Director.
**EHS responsibilities**:
- Comply with applicable EHS regulations and procedures.
- Participate in the site's EHS performance by reporting risks, malfunctions or improvements.
- Participate in mandatory EHS training
**Experience / Qualifications**
- Advanced degree in Life Sciences or Business.
- 7+ years’ experience in the pharmaceutical industry, ideally with time spent on both the Sponsor and Provider side
- Significant experience working in the Clinical Operations space (or equivalent), including managing/overseeing Service Provider (vendors).
- Previous experience directly and independently leading projects and/or a team of professionals, exhibiting the ability to influence others (above and beyond ones’ own function).
**Key Required Technical Competencies**
- ** Clinical Development expertise.** Understands the clinical trial processes, typical outsourced activities, roles and responsibilities, systems and execution challenges faced within Ipsen and Service Providers. Effectively manage Service Providers to create a symbiotic relationship between Ipsen and Service Provider.
- ** Joint problem solving.** Engages internal and external stakeholders proactively to find innovative and feasible solutions. Stru
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