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Loxo@Lilly Clinical Trial Manager, Clinical Pharmacology (Contract) in Tallahassee, Florida

Loxo@Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo@Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Louisville, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.

The Contract Clinical Trial Manager will contribute to one (or more) clinical studies including coordination of all operational aspects of the clinical study from protocol development through database lock / study closure; delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs.

Roles and Responsibilities of the Position:

  • Contribute to the execution of clinical trials, drive to solutions across a multi-functional study team

  • Anticipate and resolve complex and key technical, operational or business problems with multi-functional study team; evaluate and determine issues that require escalation

  • Use performance metrics and quality indicators to drive study execution

  • Support Health Authority inspections and CQA audits as required, including driving inspection/audit readiness through life of study

  • Collaborate with study team and/or CRO to ensure completeness & accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.

  • Proactively identify potential risks and lead the development/implementation of actions to avoid or mitigate; identify points for escalation

  • Collaborate with vendors and other study team members regarding study specific issues

  • Lead and/or collaborate in the creation and review of study documents, including but not limited to the Protocol, Informed Consent Form (ICF) and other patient facing materials, case report forms, and clinical study reports. Manage completion of these deliverables to ensure timelines are upheld. Ensure study documents are updated as needed throughout the trial

  • Plan site and country identification and selection in collaboration with internal partners

  • As appropriate per vendor/scope of work, manage and/or participate in vendor selection, specification development and management/oversight

  • Ensure management of the TMF set-up, ongoing quality review, and final reconciliation

  • Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved as required

  • Contribute to data review/cleaning of clinical data as needed and as defined by study plans

  • Manage the development/coordination of study training and study training materials for study team, investigational sites, and vendors

  • Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications

  • Ensure the collection of various study documents such as country/site insurance, CSR appendices, etc. is completed as needed

Required Qualifications and Preferred Background:

  • BA/BS degree in a relevant discipline with 5+ years’ experience in clinical drug development required Oncology and/or Hematology experience preferred and/or Clinical Pharmacology/Healthy Volunteer experience preferred

  • Experience in managing global clinical trials preferred

  • Experience with managing clinical research budgets

  • Knowledge of ICH/GCP and regulatory guidelines/directives

  • Experience with managing a multi-functional team, including leadership skills and driving deliverables

  • Demonstrates analytical approach and anticipation of problems

  • Identifies gaps and provides constructive feedback and solutions

  • Follows issues to resolution and escalates as appropriate

  • Ability to multi-task effectively and prioritize assignments from multiple sources

  • Excellent organizational skills

  • Strong communication skills, both written and oral; proficiency in English

  • Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint

  • Knowledge of study tools including electronic system skills such as CTMS/ EDC/ IRT/ eTMF

  • Knowledge of drug development process. Proactively shares information, ideas, input, and/or expertise with team members Demonstrates concern for high quality outcomes

  • Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute

Physical Demands/ Travel:

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment:

This position’s work environment is in an office.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. 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.

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).

Loxo Oncology, Inc. (“Loxo”) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email loxoaccommodation@loxooncology.com for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response.

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