Beschreibung
For one of our clients, a global pharmaceutical company, I am currently looking for a freelance Clinical Strategy & Planning Manager, ideally ASAP and for the next 18 months.Global pharmaceutical company based in Hessen, Germany.
KEY ACCOUNTABILITIES
· Responsible for preparation of high quality, realistic, cross-functional, clinical trial timelines and clinical protocol budget for R&D clinical programs from study concept through to completed clinical study report - in collaboration with the CTLs
· Responsible for resource requirement and capacity forecasting and modeling, incl. alignment with CROs
· Responsible to support teams in defining the geographic deployment of clinical trials and programs
· Responsible to lead feasibility assessments - with vendors as applicable - to support clinical trials and programs
· Assisting clinical protocol teams in developing contingency and/or risk mitigation plans to ensure timely delivery on clinical milestones
· Developing forecasts (timelines and budget) and high level plans for new trials under different scenarios in collaboration with the Clinical Operations Lead
· Responsible to support the Clinical Trial Lead in developing the preliminary and final Operational Plan to support the timely set up, and conduct of our clinical trials - also in preparation for ICSC presentations
· To drive initiatives to ensure strategic design and planning methodologies and tools are state-of-the-art and fit-for-purpose for the company's need for global and regional trials
· To ensure smooth collaboration with other functional planning groups
· To drive internal and/or external benchmarks development and maintenance as needed for study strategy and planning
· Responsible for execution of a broad range of complex tasks with established guidelines, standards and defined processes and helps determine the appropriate approach for new assignments
· Contributes to the business and financial planning process
· Other duties as assigned by line management
· Understanding of drivers of performance of a clinical trials (e.g., costs, timelines, …) and of differences across Therapeutic Areas and geographies
· Understanding of feasibility and its impact on trial complexity and hurdles to implementation
STRATEGIC IMPACT
· Assess feasibility of trial protocols for assigned projects for local trials across Therapeutic Areas, phases, and programs, ultimately influencing timelines, costs, and quality of trial-related deliverables
· Influence budget decisions for clinical trials, allowing for external clinical costs optimization
Provide input to clinical plans to ensure high-quality deliverables (in line with external benchmarks and internal standards) are submitted to ICSC ultimately impacting clinical strategy and execution (timelines and costs) for Merck Serono local trials
Management of people
Management of external providers as needed
COOPERATION
Internally
· Clinical Trial Management - providing input / aligns on trial costs for protocol
· Clinical Operations Lead - providing performance metrics
· CSSP - supporting trial delivery with CROs
Externally
· CRO and other service provider/ vendor personnel
Industry organizations (e.g., CMR) - alignment on data requests and quality
EDUCATION
Degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals)
Necessary professional experience
· At least 8 years relevant experience in drug development analytics or clinical operations
· Experience with project management tools (MS Project, PowerPoint) processes and methods
Advanced proficiency in MS office
Specifies personal skills and competencies required
· Demonstrated solid written and oral communication, interpersonal, organizational and negotiation skills, team spirit
· Demonstrated pronounced analytical skills and detail orientation
· Shows business acumen beyond the team and understands how the team integrates with other teams and how they complement and support each other
· Fluency in English (oral and written)
Position requires both domestic and international travel up to 10% of time
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