Loxo@Lilly Clinical Trial Manager, Clinical Pharmacology (Contract) in Columbia, South Carolina
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.
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 firstname.lastname@example.org 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.