Associate Director, Clinical Development Trial Lead (CDTL)

We are looking for Associate Director, Clinical Development Trial Lead (CDTL) for our client in Indianapolis, IN.

Job Title: Associate Director, Clinical Development Trial Lead (CDTL)

Job Location: Indianapolis, IN

Job Type: Contract

Job Overview:

Requirement/Must Have:

• Bachelor's degree (scientific or health-related field preferred).
• 5+ years clinical research experience or relevant experience in a scientific or health-related field.

Responsibilities:

• Leverage and demonstrate broad understanding of therapeutic, 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 timely documentation of deviations, creation of story boards or issue summary documents and coaches CDTLs in these activities.
• Network and apply 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, and share process learnings.
• Contribute to the development of others by acting as a coach for peers as well as new CDTLs, cross-functional team members and TPOs on aspects of CT process and regional specificities.
• Identify and lead process improvement activities. Acts as a CDTL SME resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as science allows.
• Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools.
• Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (Google Cloud Platform) and Lilly standards of operation in the conduct of clinical trials.
• Independently detect and resolve quality issues, escalating to functional leadership or consulting other functions to arrive at the best solution.
• Leverage 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.
• Leverage 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.
• Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials.
• Understand the scope of work required to complete the clinical trial successfully.
• Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies.
• Assess, identify and monitor trial-level risks.
• Understand the cross-functional, trial-level budget components.
• Lead, influence and project manage large, complex studies and/or multiple smaller studies.
• Partner with other organizations to coordinate and actively participate 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 deliverables.
• Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET).
• Anticipate and resolve complex and key technical operational or business problems with cross-functional study team.
• Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
• Use expertise to make timely decisions for ambiguous and complex situations.
• Manage TPO (third party organization) qualification process, selection, and oversight.
• Serve as the CRO (Clinical Research Organization) clinical development point of contact for outsourced and fully outsourced trial execution.

Nice to Have:

• Experience with oncology (early & late phase clinical trials).
• Applied knowledge of project management methodology, processes and tools.
• Demonstrated ability to lead and work effectively cross-culturally with global colleagues and with TPOs.
• Be recognized as a leader with demonstrated ability to coach others in process expertise.
• Embrace strategic organizational changes and lead others effectively through these.
• Ability to influence without authority.
• Previous experience working in cross-functional teams/projects and/or ability to establish and maintain relationships.
• Effective and influential communication, self-management, and organizational skills.
• Demonstrated ability to handle complex situations through problem-solving, critical thinking and navigating ambiguity.

Skills:

• Strong analytical skills.
• Proficiency in use of project management tools and techniques (e.g., Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI).
• Need to travel periodically to scientific/regional meetings.