Eli Lilly and Company

Clinical Program Operations Consultant

Indianapolis,, IN, United States
Oct 05, 2018
Required Education
Bachelors Degree
Position Type
Full time
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 39,000 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

Do you have expertise in leading clinical trial operations for exploratory and biopharmaceutics clinical molecules? Would you love serving as the primary operational lead from trial design through execution and close out? Are you able to model development plans and find opportunities for continuous improvement across the spectrum of Clinical Pharmacology?

Clinical Pharmacology, at Lilly, provides industry leading expertise and capabilities in early phase development and delivers efficient clinical plans, high quality submissions and approvals. The organization strengthens the impact of exploratory medicine through the integration of translational medicine.

As the Clinical Program Operations Consultant, you will 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 will be responsible for 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 deliverables), patient recruitment and retention and budget management. Other responsibilities include:
Scientific and Therapeutic Area Expertise
  • Consult with 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.
  • Maintain expertise of meaningful disease states/targets, competitors, industry trends, and operational requirements to effectively plan in detail the studies and submissions
Clinical Project Management:
  • Lead the implementation and integration of clinical project management processes and tools
  • Collaborate with Third Party Organizations (TPOs) and cross-functional partners to execute the clinical strategy and key trial deliverables on time and within budget
  • Actively identify and communicate clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates and leadership
Clinical Operations:
  • Active participant in the selection process and provide day to day oversight for operational deliverables with external network of vendors to ensure delivery of the clinical project
  • Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues, lead risk assessments and contingency planning, and effective communication across and upward
Communication and Team Management:
  • Champion a quality mindset across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources and timeline; ensuring accurate collection and communication of clinical metrics; ensuring archival of all relevant clinical information at the termination of a project and as appropriate throughout the project
  • Build and develop key partnerships and interactions/integration with the clinical team, including leadership in governance forums (if applicable)
  • Effectively and expertly communicate and influence at all levels across the organization clear and concise information to enable decision-making by team and governance/Stakeholders
  • Collaborate effectively with all colleagues; able to work with, and deliver through others
  • Navigate ambiguity and effective problem-solving/solution oriented skills to help develop and evaluate molecule level strategies from lead to legacy
  • Develop spirit of learning agility, critical thinking and the ability to think differently to incorporate new learning

Basic Qualifications
  • Bachelor's degree in a science related field.
  • 3-years' experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred).
  • Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences
  • Advanced scientific degree
  • Proven capability to influence both internal and external environments appropriately and craft strong working relationships.
  • Strong self-management, organizational and interpersonal skills with the capacity be flexible in varying matrixed environments, cross-culturally and with multiple customer groups.
  • Demonstrated knowledge and experience with project management tools and processes, managing vendors and contract experience
  • Established analytical skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent recurrence within the team.
  • Excellent oral and written communication skills; ability to communicate clearly and with team members and leadership
  • Validated experience of coaching and mentoring others.

Additional Information

  • 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