Senior Clinical Outsourcing Manager
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The Sr. Outsourcing Manager (SOM) is an integral member of the Clinical Business Operations team within Clinical Development (CD). The SOM is responsible for implementing and executing a TA or FA specific contracting and outsourcing strategy that will optimize clinical program / study delivery and costs utilizing a consistent teamwide approach and methodology. The SOM will also be responsible for participating in relevant governance structure(s) to 1) manage and monitor business relationships with critical vendors; 2) review clinical project team delivery with respect to project risks, financial forecasts, and outsourcing needs; and 3) allow for overall Clinical Development portfolio management. In doing so, this role will assist in implementing strategic direction to the CBO team and stakeholders, to promote fiscal responsibility, contract compliance, performance issue management, ensuring that CSL maintains and optimizes relationships with key suppliers to deliver value to CSL, and reporting on performance to the Clinical Development Management Team.
Main Responsibilities and Accountabilities:
1. Develop, lead and implement short-term and long-term TA and FA specific outsourcing strategies liaising with key Clinical Development stakeholders to identify potential needs, improve efficiencies and strengthen CSL’s strategic Contracting and Outsourcing approaches to best practice level. This includes all elements of outsourcing: identifying potential vendors, vendor assessment, contract negotiation and execution, and governance activities. Oversee the negotiation of CDAs, contractual terms, rate cards, and other contractual items with all vendors, including but not limited to central laboratories, systems vendors, niche suppliers and consultants and will work with CD global teams in the selection of niche vendors and specialized consultants through defined processes (which may include Request for Information, Request for Proposal, or other Due Diligence activities).
2. Create operational cost modeling and scenario planning to support build versus buy decisions utilizing both internal & external inputs as required. Compile and analyze into cohesive recommended strategies and present to appropriate management teams e.g CDOF.
3. Work across CBO, Contracts Managers, Outsourcing Managers, Governance Manager, Clinical Outsourcing Specialists and other Clinical Development stakeholders to ensure that processes and tools are followed to monitor contractual obligations and responsibilities of CSL, as outlined in global CD initiated Master Service Agreement/ Contract/ Consultancy Agreement/ Work Orders, and that they are tracked and upheld, ensuring CSL remains protected and in compliance with contractual obligations at all times. Ensure that new project work is efficiently and effectively communicated to CSL’s external service providers, including review of RFPs and RFQs prepared by Clinical Outsourcing Specialists and addressing questions raised by vendors in the preparation of quotations or proposals.
4. Work with the cross functionally within Clinical Business Operations, the Business Operations Management, Business Performance Management, Global Project Leads and other key Clinical Development personnel to ensure that vendor spend in support of global Clinical Development programs is in compliance with the negotiated MSA/contractual terms and rate cards and within approved forecasts and budgets.
5. Ensure that any contractual terms agreed are understood by relevant Clinical Development and Legal responsible individuals so that the Company and its vendors meet their legal obligations. This includes helping the Responsible Person (related to a contract) understand and carry out his/her responsibilities.
6. In collaboration with Business Performance Management support the systems and processes in place to effectively manage and monitor business relationships with critical vendors and ensure they deliver as required. This will be done by participating in a tiered vendor governance structure including project teams, operational governance, and executive committees as defined by Business Performance Management.
7. Develop and maintain strong working relationships with both internal and external collaborators and stakeholders across all CSL geographical regions. Support all End to End CBO Processes to drive operational efficiencies.
Position Qualifications and Experience Requirements:
Degree (Bachelors) in a Business related and /or scientific/medical/pharmaceutical discipline, preferably combined with relevant clinical trial experience with a business focus.
- Minimum 7 years relevant Clinical Business Management experience, of which at least 4 years were in clinical outsourcing and/or external service provider management with a CRO and or Pharmaceutical company.
- Must have a comprehensive understanding of clinical development processes and management of clinical studies including cost structures.
- Strong understanding of contracts and legal terms.
- Proven leadership and global Clinical Operations experience is essential
- Involvement in cross-functional, multicultural and international teams preferable.
- An ability to solve problems and issues of a complex nature which demonstrate the ability to develop value-added solutions.
- An ability to understand all tasks involved in the clinical trial process from developing a protocol through to finalizing a study report.
- Exhibits strong negotiation skills and is able to identify and engage internal and external expertise as needed.
- Thinks strategically with strong analytical skills to manage competing demands while remaining objective.
- Strong verbal, written and presentation skills.
- Excellent planning, organizational and decision making skills.
- A commitment to producing high quality work product with an attention to detail.
- Ability to be proficient in conflict resolution and conflict management.
- Proficiency in MS Word, PowerPoint, Project, Excel.