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Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Hyderabad, Andhra Pradesh, India
Job Description:
IDAR – Business Operations
Position Title: Associate Director Business Operations
Job Location - Hyderabad
Position Summary:
Integrated Data Analytics and Reporting (IDAR) comprised of: Data Management & Central Monitoring, Clinical Data Standards and Transparency, Regulatory Medical Writing, Clinical & Statistical Programming,
Integrated Clinical & Operational Analytics, Clinical & Portfolio Systems, and Business Operations. IDAR is part of the Global Development organization in the Innovative Medicines organization.
IDAR Business Operations (IBO) is accountable for establishing, maintaining, and continuously optimizing business operational activities, to enable high quality deliverables (time, cost, and quality), with a
particular focus on leading strategy & operations for IDAR. This is accomplished by utilizing a broad knowledge of IDAR functions, drug development, and business operations, developing highly effective
cross-functional relationships and leveraging data/insights to enable value added deliverables.
Key focus areas are:
- Financial & Resource Management
- Business Management
- Operational Excellence
- Business Oversight of Vendors
This position will drive the analytical, tactical, and business operational oversight of providers to ensure high quality, regulatory compliant and efficient operations. The position will report to the Director of Business Operations overseeing Business Oversight of Providers.
Primary Responsibilities:
- In collaboration with Procurement and/or Partnerships, drive the implementation of sourcing strategies in IDAR
- Manage the operational business driven oversight framework of providers to ensure a compliant, consistent, well-documented, and aligned approach with Partnerships & Procurement governance model/policies across all sourcing models.
- Monitors cost and comparison models for outsourced studies to continue driving cost effectiveness.
- Maintains a clear overview of supplier spend. Assists in invoices and payments reconciliation against contracts and supplier delivery with IBO Central Services and functional teams, as needed. Investigates and documents trends and implements solutions.
- In collaboration with the IDAR Business Operations Leads, assesses the accuracy of demand forecasting to ensure providers have insight into upcoming changes to the book of work. Implements improvements in collaboration with stakeholders. Provides insights into improving the accuracy of forecasting. Partners with function, Procurement, and Partnerships to build a robust framework of working in a collaborative manner with clear R&Rs.
- Take a leadership role in establishing best practices for provider effectiveness across all providers partnering collaborating with IDAR functions.
- Participates in and/or leads global cross-functional and cross-company initiatives, as applicable.
- Responsible for overall audit readiness and training compliance for all suppliers in collaboration with the Head of IDAR Compliance Management.
- Coordinates ongoing analysis of risk to supplier performance (in alignment with functional experts, Partnerships and Procurement) in the respective sourcing model, deliverables, financial and compliance/regulatory domains working collaboratively with the appropriate IDAR functional experts.
- Maintains business level oversight plans which include clear documentation of the transfer of responsibilities (where appropriate) for defined, in scope services.
- In conjunction with the IDAR functional experts and IDAR Compliance Manager, develops and recommends risk mitigation, contingency plans, and corrective or preventative actions to improve quality and compliance and address systemic issues.
- Accountable for the operations of oversight meetings, including meeting setup, logistics, agenda, minutes, follow-up action items, and the central storing of documentation for inspection readiness purposes.
- May be a member of governance committees owned by Partnerships.
- Collaborate with Partnerships and Providers to translate business needs into requirements and projects. Ensures new services are developed effectively and results are acceptable. Provides insights and improvements to the working relationship with Procurement/Partnerships and drives the implementation of new ways of working.
- Accountable for consolidating, providing, and driving other inputs for business planning.
- Leading and implementing consistent operational processes across IDAR, driving best practices, sharing key learnings, and providing guidance. Coordinates and leads (as assigned) key strategic initiatives to help improve the overall performance of IDAR against business priorities.
- In collaboration with Partnerships/Procurement and functional experts, defines and continually refines service and operational metrics for measurement and reporting.
Principal Relationships:
Primary Reporting Structure: Reports to the Director, Business Operations Lead Supplier Driven Oversight.
Primary interfaces: Functional Leadership Teams, IDAR, Partnerships, Procurement.
Other Internal Interfaces: BGIA, Finance, Capacity Management, HR, Functional Communications, Initiative Leaders.
External Interfaces: as required.
Education and Experience Requirements:
- A minimum of a bachelor’s degree (University/college degree) in a scientific discipline or general management is required. Master’s degree preferred .
- A minimum of 5 years of experience in clinical operations either in a direct or supporting function is preferred. Experience in managing CRO/BPO/Flex suppliers is preferred.
- A minimum of 8-10 years of experience in diverse professional experience encompassing program/project management, business operations in the pharmaceutical/biotech industry is required.
- People management experience is mandatory.
- The ability to multi-task, work with minimal supervision, make decisions, and achieve results in a fast-paced environment is required.
- Experience in managing internal stakeholders is required.
- Excellent communication and influencing skills.
- A good understanding of clinical development, and data management, clinical data programming, clinical risk management – central monitoring, technical functions such as clinical and portfolio systems, and medical writing practices is preferred.
- Experience in working in cross-functional teams and managing large projects.
- The incumbent should have a working knowledge of regulatory guidance documents such as ICH requirements, inter-departmental processes, and relevant Clinical R&D concepts.
- In-depth knowledge of project management, team leadership and people development practices is required.
- This position requires knowledge related to building effective partnerships internally and externally.
- This position also requires knowledge of sourcing strategies, resource management, and organizational impact.
- Operates and executes without supervision.
- Refined oral and written communication skills, including effective negotiation, influencing, and active listening.
- Strong customer focus and belief in Credo values.
Other:
Up to 5% international travel is required.
Required Skills:
Preferred Skills:
Budgeting, Clinical Trial Designs, Clinical Trials, Compliance Management, Consulting, Contract Management, Execution Focus, Fact-Based Decision Making, Give Feedback, Industry Analysis, Laboratory Operations, Organizing, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Technical Credibility
