Sr. Clinical Outsourcing Mgr.
AstraZeneca (Delaware, Delaware)

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Description:

Leading program level outsourcing activities across functions and globally as assigned, ensuring that the Outsourcing Strategy and current decision-making processes are applied. Leading the evaluation and selection of external vendors, using recognized criteria, including audits and feedback from previously conducted projects. The role require a high level of interactive communication as well as cultural sensitivity to set clear direction for the team and when managing external service providers.
Influence business by strongly impacting the decisions through the allocation and management of clinical service resources. Contributes to the global and local development of outsourced operations and processes. The role holder manages high-level risk by making complex judgements, developing innovative solutions and applying a comprehensive cross-functional and industry understanding.

Accountabilities/Responsibilities:
1. Lead and support the external delivery solution (Outsourcing) for Drug Projects
Provide the project/study teams with the bigger picture, consistent outsourcing direction and ensure that quality sourcing processes and tools are consistently applied across project teams.
Provide contract and negotiation expertise in finalization of agreements, including re-negotiation if and when appropriate.
Drive the contract management process as defined in the Outsourcing SOP and facilitate training to the project/delivery teams.
Lead global cross-functional teams and participate in the evaluation and selection of external vendors, using recognized criteria, including audits and feedback from previously conducted projects.
Interact with Marketing Company representatives to ensure optimal communication between vendors, Marketing Companies and R&D Sites.
Lead special project teams for example in selection of niche providers, establishing global procedures, developing internal training programs for working with clinical vendors as appropriate.

2. Negotiation of optimum terms, conditions and fees for external services
As a key member of the project/delivery teams
Analyze project teams outsourcing requirements to identify and plan for utilization of suitable vendor(s) and services.
Lead reduction of transactional management cost through strategic outsourcing.
Manage the RFP process and provide cost analysis, including bid comparisons and review of unit costs against MSAs where appropriate.
Drive financial terms and conditions of multimillion-dollar contracts and purchase of specific services
Interact with external service providers and internal team leaders during contract procurement/negotiation, development and management processes.
Ensure that implications of scope changes within the study are understood from a contract/budget perspective.
Develop appropriate performance metrics and ensure that performance metrics are incorporated into contractual documents and manage supplier performance against the contract.
Responsible for reporting all savings made in the Value Database on a quarterly basis and coordinating the savings validation with Finance as required.
Interface with Legal, Intellectual Property and Insurance departments to ensure integrity of contracts.

3. Project Management and Risk Assessment of Outsourcing Solutions

Lead risk assessment processes within provider due diligence process for niche preferred/non-preferred providers, provider systems audits (including financial and IT) and coordinate all follow-up findings.
Guide project/delivery teams in managing issue identification, escalation and resolution for global/local providers and ensure ongoing assessments of overall CRO performance, liaising with the Business Relationship Managers as appropriate.
Liaise with Finance and teams as required to support CRO budget management.

4. Ensure the Outsourcing Process is Compliant with Corporate Governance

Ensure compliance with Section 404 of Sarbanes Oxley Act of 2002, ICH GCP, the Global Outsourcing Strategy and Procedures, and Corporate Policies.
Leads awareness sessions for corporate governance.
Promote and ensure positive working relationship and collaboration with Purchasing, where appropriate.
Take ownership of and be responsible for the QC/QA of the following documents: RFP, Start Up Agreements, Project Agreements and Amendments, and any other contractual documentation.
Responsible for the production of the following documents: RFPs, Start Up Agreements, Project Agreements and Amendments.

5. Knowledge Management

Lead local and global initiatives to ensure standard processes and procedures as well as continuous improvement in the Outsourcing arena, including specific projects to ensure Sarbanes Oxley compliant process improvements where required and projects to ensure integration of Clinical Outsourcing into AstraZeneca Capacity Management.
Responsible for the identification, development, implementation and leadership of process improvement.
Keep abreast of best contracting practices both within and outside of industry.
Actively promote sharing best practice, knowledge management/transfer process within local and global outsourcing network and project teams.
Accountable for cases in MEXICO by entering case core information at Contract Award and agreement information at contract finalization, including committed spend.
Ensure that all tools are updated as appropriate including performance metrics, PKT and the Bidder Tool (on contract finalization).

6. External Supplier Management

Provide experiences on preferred providers to Global Account Managers and participate at CRO forums for preferred and niche providers as appropriate.
Analyze CRO costs and delivery to identify trends and to benchmark against industry standards.

Additional Accountabilities

1. Mentoring and Coaching
Provide coaching/training/mentoring support as required to new/less experienced Clinical Outsourcing Managers.
Recognize and develop team members’ competencies to meet goals, including coaching/mentoring others in the section and developing/implementing an induction program for new starters.

2. Relationship Management
Lead implementation of elements of Global Outsourcing Strategy Workstreams and Strategic Sourcing Solutions.

Responsibilities

Minimum Requirements –Education and Experience

University degree or equivalent
Minimum of 7 years pharmaceutical, CRO or equivalent experience.
Minimum of 5 years contract negotiation experience.
Extensive knowledge of contract and outsourcing management, with specific reference to the pharmaceutical/health care industry, and be seen as a source of reference on these matters.
Demonstrated knowledge of contracting/commercial processes and the CRO industry.
Good understanding of project management tools and processes.
Extensive knowledge of clinical and pharmaceutical drug development process at various phases of development

Preferred Background
A strong knowledge of the precepts of Corporate Governance requirements

Skills and Capabilities
Proven leadership skills in global drug development including the motivation and empowerment of others in order to accomplish individual, team or organizational objectives.
Able to apply strategic direction to a team or project.
Manages changes with a positive approach to the challenges for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
Require cultural sensitivity when dealing with a wide range of key customers both within AZ and when representing the company externally.
Communicate confidently and competently across cultural boundaries at all levels and liaise with others through excellent communication and negotiation skills.
Demonstrated ability to manage priorities, resources and project initiatives in a global and regional environment