Overview
The Clinical Trial Project Manager (CTPM) Associate leads the cross-functional study team in the development and execution of clinical trials and is accountable regionally and globally to deliver trials with quality, on time, within scope and budget. The CTPM Associate leverages project management, regional operational knowledge, clinical trial process leadership and scientific expertise to drive actions and coordinate efforts to achieve or exceed trial deliverables.
Responsibilities
* Project Management, and Regional Operational Knowledge: Use project management skills, processes and tools to develop and execute local, regional and/or global clinical trials. Include scope management, timeline development, risk assessment and mitigation, and budget planning with cross-functional collaboration across geographies.
* Coordinate training: Partner with other organizations to participate in Investigator Study Specific Training (ISSTs) and Affiliate Study Training (ASTs).
* Study execution leadership: Drive and coordinate local, regional and global cross-functional study teams throughout study implementation, execution and closure, including issue management, contingency planning and issue resolution.
* Enrollment strategy: Be accountable for trial/regional enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET); partner with Regional Operations to achieve regional enrollment goals.
* Communication and relationships: Manage relationships and serve as a single point of contact for trial communication to and from the CPM Organization, Regional Clinical Operations, and third-party organizations (TPOs).
* Problem-solving: Apply problem-solving skills to daily issues with cross-functional study teams (including vendors, affiliates/regions, global team members and other business partners).
* Continuous improvement: Identify and help develop continuous improvement activities based on industry trends, regulatory changes, new technology, etc.
* TPO oversight: Manage TPO qualification, selection, and oversight.
Clinical Trial Process Leadership and Expertise
* Demonstrate understanding of the drug development process and the inter-relatedness of cross-functional activities; look for opportunities to expand clinical trial process expertise.
* Coordinate with the global and regional operating model and facilitate regional input for study teams.
* Single point of accountability for the Trial Master File, ensuring it is current and inspection ready.
* Anticipate trial and regional issues, identify process breakdowns, and propose proactive approaches to reduce risks that impact delivery.
* Lead and influence in ambiguity; coach peers, cross-functional team members and TPOs on trial processes and regional specifics.
* Report and interpret information for trials across multiple systems from study implementation through closure.
* Apply knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards; liaise with affiliates to understand local regulatory requirements.
Scientific Expertise
* Provide technical consultation for clinical and regulatory documents and prepare for regulatory meetings; draft responses to questions from regulatory agencies, TPOs and affiliates.
* Integrate scientific, regional and operational knowledge to impact trial design, feasibility and implementation.
* Apply clinical development knowledge, problem solving and critical thinking to support business needs.
Minimum Qualification Requirements
* Bachelor’s or university degree (scientific or health-related field preferred) and 3 years of clinical research experience or relevant experience; or an advanced degree.
Highly Desired Skills
* Applied knowledge of project management methodology, processes and tools
* Ability to work cross-culturally with global colleagues and with TPOs
* Ability to influence without authority
* Strong leadership and networking skills in cross-functional and cross-cultural teams
* Effective communication, self-management, and organizational skills
* Problem-solving, critical thinking and ability to navigate ambiguity
* Flexibility to adjust to changing priorities
* Exploratory and biopharmaceutics clinical development experience preferred
* Ability to oversee and influence TPOs to enable delivery of trial deliverables
* Minimum of 3 years clinical trial experience with knowledge of the clinical research process
* Prior clinical trial site-level or affiliate experience
* Proficiency with project management tools (e.g., MS Project, MS Excel, MS PowerPoint)
* Ability to travel up to 10%
Note: We encourage employees to discuss opportunities with their supervisor prior to applying. 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. WeAreLilly
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
* Industries: Pharmaceutical Manufacturing
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