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Clinical Project Manager - Early Phase

Bracknell, United Kingdom

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Req ID R-24920 Title Clinical Project Manager - Early Phase City Bracknell Country United Kingdom Region Research

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Clinical Project Manager
Bracknell, flex working

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.

 

We're looking for an experienced Clinical Project Manager to lead the creation and execution of the exploratory and biopharmaceutics clinical operational development plan at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan.

 

You'll plan and deliver phase-I molecule and submission clinical achievements on time and on budget throughout the molecule lifecycle. Your responsibility spans all aspects of global clinical trial operations within the plan, as the single operational point of contact from trial design through execution and close out, including timeline creation and management, outsourcing plan, vendor management (including direct oversight of the operational results), patient recruitment and retention and budget management. Dependent on the operational/resource model chosen and influenced by the needs of the clinical development program, you may be assigned additional trial level management support from internal or external resources. Naturally you will seek knowledge from internal and external sources and use this information to shape development plans and seek opportunities for improvement.

 

Primary Responsibilities:

 

Scientific and Therapeutic Area Expertise

  • Provide consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications and manuscripts.
  • Stay up-to-date with current body of knowledge of relevant disease states/targets, competitors, and industry trends and standard methodologies.
  • Maintain knowledge of operational requirements to effectively plan in detail exploratory and biopharmaceutics clinical development studies and submissions

Clinical Project Management:

  • Lead with expertise on the implementation and integration of clinical project management processes and tools.
  • Work with Third Party Organisations (TPOs) to execute the defined clinical strategy, leading all aspects of key trial results.
  • Develop and maintain up-to-date clinical plan timelines and process maps
  • Partner with the financial organiation, cross-functional partners, and geographies, to develop and manage the overall clinical budget for the molecule level book of work including initiation and management of the change process.
  • Proactively identify and communicate clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates and leadership.

 

Clinical Operations:

  • Accountable and responsible for oversight of clinical trial operations and delivery of clinical project achievements on time, on budget
  • Create and manage implementation timeline and clinical trial activities
  • Involved in selection process and management of vendors, providing day to day oversight for operational deliverables with external network of vendors to ensure on time and on budget clinical project deliverables
  • Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and communication across and upward
  • Partner with regulatory and medical to ensure safety management and monitoring processes are implemented

 

Communication and Team Management:

  • Influence and work with quality approach across the clinical team
  • Manage key relationships and interactions/integration with the clinical team

Leadership

  • Collaborate effectively with colleagues at all levels; able to work with, and deliver, through others.
  • Skilled at working through ambiguity and effective problem-solving/solution oriented skills to help develop and evaluate molecule level strategies from lead to legacy.
  • Successful in persuasion and influence in a matrix environment.

Basic Qualification:

  • Bachelor’s degree
  • Several years of direct experience of project managing clinical studies

 

Additional Preferences:

  • Advanced scientific degree
  • Experience ideally in exploratory and biopharmaceutics clinical development (Phase I)
  • Vendor management experience.
  • Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
  • Strong self-management, organsational and interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
  • Strong leadership and networking skills.
  • Demonstrated ability to work effectively cross-culturally and in a virtual work environment.
  • Demonstrated knowledge and experience with project management tools and processes.
  • Demonstrated problem-solving skills
  • Excellent oral and written communication skills
  • Ability to influence and oversee TPOs to enable delivery of trial level deliverables.
  • Proven experience of coaching and mentoring others.
  • Ability to travel (up to 10% expected)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-24920.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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