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Employer Sponsored Job (Free to apply to)
PAREXEL International Corporation Job Title
Proposal Reviewer, Clinical Operations Manager

PAREXEL International Corporation

Job Description
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Jobs at Parexel
We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it
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Proposal Reviewer, Clinical Operations Manager
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Job ID
Poland - Any Region - Home Based
To actively engage and work with different experts across Parexel in the development of ICH GCP compliant clinical solutions for new studies. Review proposed clinical operations strategies for ability to execute operationally with efficiency, competitiveness, and profitability.
Key Accountabilities:
Provide wholistic proposal review across all GCO portions of the project opportunity including feasibility, SSU, Site Management, COL oversight, and TMF
Work in partnership with Commercial Operations, Project Leadership and across Global Clinical Operations departments to optimize new business opportunities
Review and provide feedback on the development of efficient, competitive and profitable solutions
Ensure clinical milestones, scope and hours budgeted are achievable taking into account technology planned, region/countries specifics (if applicable) and client preferences
Ensure appropriate assumptions are included in budget
Support, participate in and contribute to bid pursuit meetings as needed.
Maintain extensive knowledge of relevant clinical offerings, Parexel systems and other technologies
Maintain knowledge of industry trends and requirements aligning with Regulatory Authority (FDA, EMA, MHRA, etc..) guidance including but not limited to ICH E6 R2
Expert in clinical algorithms leading the review and update as required using a data driven and risk based & quality management approach to revisions
Consult with and support, as required, clinical delivery team and clinical management
Approval rights on behalf of GCO (to agreed thresholds) for proposed efficiencies or hours reductions proposed for the opportunity
Provide input into Request For Information (RFIs) and liaise with functional groups in GCO to ensure RFI responses are current, reflect new systems and processes.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Significant budgetary and scoping knowledge
Connection between operationalizing a proposed study and maintaining profitability in a competitive environment
Demonstrated experience in stakeholder/relationship management with a client focused approach to work. Able to understand the business implications of decisions
Excellent interpersonal, verbal, and written communication skills
A flexible attitude with respect to work assignments and new learning
Attention to detail and ability to deliver against deadlines
Ability to work in a matrix environment with strong negotiation and project management skills
Excellent analytical/critical thinking and problem-solving skills
Language Skills:
Fluent in written and oral English
Knowledge and Experience:
Multiple years of work experience in clinical research with substantial knowledge of clinical operations
Therapeutic knowledge in one or more of these targeted areas highly preferred: oncology, immunology, infectious disease, cell and gene therapy, rare disease
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or relevant clinical or business equivalent.
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