Proposal Reviewer, Clinical Operations Manager

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. QualificationsSkills: 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 Education: Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or relevant clinical or business equivalent.