Job DescriptionProvide wholistic proposal review across all GCO portions of the project opportunity including feasibility, SSU, Site Management, COL oversight, and TMFWork in partnership with Commercial Operations, Project Leadership and across Global Clinical Operations departments to optimize new business opportunitiesReview and provide feedback on the development of efficient, competitive and profitable solutionsEnsure clinical milestones, scope and hours budgeted are achievable taking into account technology planned, region/countries specifics (if applicable) and client preferencesEnsure appropriate assumptions are included in budgetSupport, participate in and contribute to bid pursuit meetings as needed.Maintain extensive knowledge of relevant clinical offerings, Parexel systems and other technologiesMaintain knowledge of industry trends and requirements aligning with Regulatory Authority (FDA, EMA, MHRA, etc..) guidance including but not limited to ICH E6 R2Expert in clinical algorithms leading the review and update as required using a data driven and risk based & quality management approach to revisionsConsult with and support, as required, clinical delivery team and clinical managementApproval rights on behalf of GCO (to agreed thresholds) for proposed efficiencies or hours reductions proposed for the opportunityProvide input into Request For Information (RFIs) and liaise with functional groups in GCO to ensure RFI responses are current, reflect new systems and processes.
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.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.Significant budgetary and scoping knowledgeConnection between operationalizing a proposed study and maintaining profitability in a competitive environmentDemonstrated experience in stakeholder/relationship management with a client focused approach to work. Able to understand the business implications of decisionsExcellent interpersonal, verbal, and written communication skillsA flexible attitude with respect to work assignments and new learningAttention to detail and ability to deliver against deadlinesAbility to work in a matrix environment with strong negotiation and project management skillsExcellent analytical/critical thinking and problem-solving skills
Fluent in written and oral English
Knowledge and Experience:
Multiple years of work experience in clinical research with substantial knowledge of clinical operationsTherapeutic 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.
Why Work at Parexel
There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?
That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.
How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.