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Proposal Reviewer, Clinical Operations Manager

Employer
Parexel
Location
Croatia
Salary
Competitive
Start date
1 Aug 2022
Closing date
18 Aug 2022

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Job Description

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.


  • Qualifications

    Skills:
  • 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.


  • 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.

    Company

    Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

     

    Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

     

    Find Us
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
    Uxbridge
    Middx
    UB8 1LZ
    GB
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