Associate Director-Clinical Trial Project Management in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Associate Director-Clinical Trial Project Management in Indianapolis, Apply Lilly careers in Indianapolis Indiana.

 

Position : Associate Director-Clinical Trial Project Management

Location : Indianapolis, Indiana

Job id: R-34229

 

Job Details

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.At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.Purpose:The Associate Director – Clinical Trial Project Manager (CTPM) independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally for on-time delivery of clinical trials with quality and within scope and budget. The Associate Director – CTPM consistently demonstrates independent leadership, influence when working with study teams, management, and business partners, and prospective identification of potential issues and solutions.Responsibilities:Project Management, and Regional Operational KnowledgeBroader responsibilities at Therapeutic Area/ Molecule/Indication level.Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT) as described:Scope – Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make adjustments as needed to meet the needs of the trial.Timeline – Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies. Provide consultation and mentorship to CTPMs on their Integrated Plans.Risk – Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to build one integrated trial-level risk mitigation and contingency plan.Budget – Understand the cross-functional, trial-level budget components. Build and monitor the overall budget and assumptions using financial tracking tools. Routinely network with appropriate business partners on trial-level budget status and changes. Function as point of contact for other CTPMs on their clinical team as needed regarding budget items.Lead, influence and run large, complex studies and/or multiple smaller studies.Partner with other organizations to coordinate and actively engage in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).Independently drive and influence local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial results, including proactive issue management, contingency planning and issue solution. Drive to solutions across the molecule/program.Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET)Partner with the Regional Operations to achieve regional enrollment goals.Foster relationships and serve as a single point of contact and central owner for trial communication. Effectively manage and influence upward.Anticipate and resolve sophisticated and key technical operational or business problems with cross-functional study team (including vendors, affiliates/ regions, global team members, and other business partners) with little/ no need for direct management support. Evaluate and determine issues that require leadership involvement.Apply expertise to make decisions for ambiguous and complex situations. Uphold a consistent, outcome driven approach to conducting daily business.Demonstrate credibility and influence to enable teams and multiple business partners, both internally and externally, to make effective and decisions.Oversight of TPO qualification process, selection, and oversight.Clinical Trial Process Leadership and ExpertiseDemonstrate broad understanding of therapeutic area, clinical drug development, and process expertise in order to influence study design and program-level decisions considering regional needs.Recognize inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise across functional teams, regions, and external partners and make decisions on process and issues affecting study implementation and execution.Be knowledgeable on the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams.Single point of accountability for the Trial Master File for assigned trials, working closely with functional record owners to ensure the file is current and inspection ready at all times.Ensure inspection readiness of respective clinical trial(s). Ensures on time documentation of deviations, creation of issue summary documents and coaches CTPMs in these activities.Network and tap into expertise to anticipate trial and regional issues, identify areas of process breakdown, analyze situations and propose innovative approaches that positively impact ability to deliver the clinical trial while reducing and/or mitigating risks. Share process takeaways in order to benefit the Lilly portfolio.Contribute to the development of others by acting as a coach for peers as well as new CTPMs, cross-functional team members and TPOs on aspects of CT process and regional specificities.Provide shared learning opportunities within their clinical teamIdentify and lead process improvement activities. Acts as a CTPM SME resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as the science allows.Lead decisively in the midst of ambiguity.Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools. Be instrumental in driving regional clinical operational processes and methodologies used.Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.Independently detect and resolve quality issues, advancing to functional leadership or partnering with other functions (e.g., Medical Quality, Legal, Compliance, etc.) to arrive at the best solution.Scientific ExpertiseUse scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.Combine scientific regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.Use clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.Function as point of contact for Therapeutic Area and/or disease state expertise for others on their clinical team.Basic Requirements:Bachelor degree (scientific or health-related field preferred) and 5 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree.Additional Skills/Preferences:Applied knowledge of project management methodology, processes and toolsDemonstrated ability to lead and work effectively cross-culturally with global colleagues and with TPOsBe recognized as a leader with demonstrated ability to coach others in process expertise.Embrace strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered prioritiesAbility to influence without authorityPrevious experience working in cross-functional teams/ projects and/or ability to establish and manage relationshipsEffective and influential communication, self-management, and organizational skillsDemonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguityMinimum of 5 years clinical trial experience with a strong working knowledge of the clinical research processPrior clinical trial site-level or affiliate experiencePrior experience with local/country/regional requirementsStrong analytical skillsProficiency in use of project management tools and techniques (e.g., Critical Chain, ProChain Enterprise, MS Project, MS Excel, MS PowerPoint)Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetingsEli 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 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.Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). #WeAreLilly

 

 

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