Clinical Research Associate

58545 - Manager, optimization and planning

The opportunity:

The Manager, Optimization and Planning is responsible for supporting early planning initiatives, evaluation and protocol optimization processes within Global Clinical Operations (GCO) – Innovative Medicines and Biosimilars. This role will include managing processes by utilizing various industry tools, such as Real-World Data analytics to support study design development. In addition, manage early project initiatives from start to implementation may be required ad-hoc, such as decentralized evaluation and implementation in studies.

This role will be a combined independent and collaborative role, to lead and support development and implementation of new/innovative/creative planning methodologies including identifying and managing stakeholders, defining project scope, working with internal and external teams, managing timelines, metrics and deliverables.

How you’ll spend your day:

• Lead the evaluation and assessment of the protocol related to optimization initiatives for clinical trial success, which may include but not limited to population evaluation, eligibility criteria, burden of study, etc. Work in collaboration with internal and external functions to ensure efficient processes are being planned, agreed, and executed.
• Lead cross functional team meeting including internal Teva teams (operations, clinical development, procurement, health economics and outcomes research, finance etc.) and external suppliers/vendors (CRO, others) through early engagement process to support the insight generation for the program and protocol development
• Support TOPS Lead on overall strategy for operational and planning processes to bring innovative or creative approaches, optimized and efficient processes to other/new early project initiatives, for example decentralized strategy.
• Working with TOPS Lead to re-evaluate methodologies in the areas of optimization and planning including monitoring the marketplace for new vendors, redefining internal processes by gaining supportive information from industry benchmark and competitive intelligence.
• Strong ability to transition analytical outputs to presentation format and deliver the presentation to multi-level functions and teams.
• Identifies and aligns with the Teva values, work respectfully, knowledgeably, and effectively with all nationalities in a global environment.
• Ensure timely, efficient and high quality deliverables in all projects.

Your experience and qualifications:

• Bachelors or higher degree in Science, Industrial Engineering, or equivalent combination of education and related work experience
• At least 2-3 years' experience as a project manager in Clinical trial planning/feasibility departments, study start up team, study manager or equivalent in other sponsors, CRO or relevant vendors.
• Knowledge of standard Windows programs (Word, Power Point, Outlook etc.).
• Ability to effectively interact with and influence others without direct reporting relationships
• Experience in setting new methodologies and processes in clinical trials related organizations
• ICH-GCP
• A proven knowledge in clinical trials and clinical development processes
• Understanding of clinical data and pharmaceutical development
• Strong written and verbal English
• Strong resources management and project management skills