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Project Director, Clinical Development

1 week ago

Québec, Quebec, Canada Syneos Health Full time

About Syneos Health

At Syneos Health, we accelerate customer success to bring new therapies to patients faster.

We are a leading fully integrated biopharmaceutical solutions organization that translates unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model puts the customer and the patient at the center of everything we do. We continuously seek ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.

As part of our team, you'll collaborate with passionate problem solvers who innovate together to help our customers achieve their goals in a fast-paced, high-tech environment.

Discover why 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Join Us?

  • We invest in developing our people through career development and progression, technical and therapeutic area training, peer recognition, and total rewards programs.
  • We're committed to our Total Self culture, where you can be authentically yourself. Our Total Self culture unites us globally, and we take care of our people.
  • We build the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.

Job Responsibilities

You will provide oversight for all assigned projects to ensure study launch, conduct, and closeout occur according to the Customer's and company's contractual agreement. Ensure studies progress according to internal and Customer quality standards, SOPs, GCPs, and ICH guidelines to fulfill all federal and local regulations.

  1. Forecast, prioritize, and direct staff to achieve on-time sponsor deliverables with quality and in accordance with contracted scope and Customer expectations.
  2. Collaborate with Therapeutic Strategy and Innovation teams to provide operational input in support of proposal development and pricing, including the proposed operational strategy.
  3. Drive preparation and facilitation of bid defense meetings in collaboration with Therapeutic Strategy and Innovation teams and Business Development.
  4. Provide oversight to project management teams in driving management of financial aspects of assigned projects, including executed contracts, CNFs, change orders, forecasting, invoicing, etc.
  5. Actively mentor project delivery oversight staff in leadership skills, customer management skills, project management skills, Trusted Process compliance, and for project-specific tasks.
  6. Troubleshoot difficulties that may arise in project conduct between the company and Customer and manage escalations appropriately. Facilitate team building and communication. Act as a liaison and facilitator between other functional areas for overall operational issues.
  7. Develop and maintain knowledge of evolving trends related to therapeutic areas, competitive landscapes (e.g., standard of care), and drug development trends.
  8. Support teams in regularly and comprehensively assessing and mitigating risks on their projects to assure patient safety, data integrity, and quality project delivery.
  9. Participate in corporate initiatives and/or represent Project Management in regional or business activities. Serve as a subject matter expert in support of and may provide training on CSO Consortia Model.
  10. Participate in the project Risk Review meeting process.
  11. Liaise with Project Sponsors and teams to promote optimized application of project management disciplines and approaches within a fast-paced, high-tech environment.
  12. Share lessons learned and best practices across programs, building relationships with key stakeholders cross-functionally, across all levels.
  13. Support Change Management, including adjustments based on emerging business or technical opportunities and challenges.
  14. Maintain senior management-level relationships with Customers via routine meetings (e.g., 1:1's with counterparts), governance meetings, and other forums.
  15. May have direct reports.

Qualifications

What We're Looking For:

  • Requires a BA/BS in the life sciences, nursing degree, or equivalent education or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company.
  • Prior cross-functional project management experience within the clinical trial industry is required.
  • Pharma/CRO experience is required, to include client relationship management.
  • Thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures is necessary.
  • Demonstrated proficiency with ICH/GCP guidelines.
  • Proficiency in Microsoft Office Suite (Outlook, Teams, Word, Excel, PowerPoint, etc.).
  • Demonstrated ability to manage multiple tasks within a dynamic projectized matrix team environment is essential – all while assuring project delivery on time and with quality.
  • Requires strong presentation, documentation, and interpersonal skills as well as a team-oriented approach.