Associate Director or Director, Clinical Operations
Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.
The Clinical Research Associate, in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.
Roles and Responsibilities of the Position*
Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
Use performance metrics and quality indicators to assist the Clinical Trial Manager in driving study execution.
Participate in monitoring visit report review process to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
Support Health Authority inspections and CQA audits as required.
Ensure full compliance (completeness and accuracy) of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
Provide proactive identification of potential risks and develop and implement actions to avoid or mitigate.
Develop and maintain collaborative relationships with internal and external partners/stakeholders.
Study Planning and Conduct:
Collaborate with vendors and Loxo CTM’s regarding study specific issues and follow through to resolution.
Assist in the creation and review of study documents, including but not limited to the Protocol, Protocol Synopsis, Informed Consent Form (ICF) and other patient facing materials and assist in updating these study documents as needed.
Participate in vendor specification development and management/oversight.
Assist with management of TMF set-up, ongoing quality review, and final reconciliation.
Assist with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
Actively contribute to study meetings including presenting as a subject matter expert, generating, finalizing and distributing study team agendas and recording meeting minutes as needed.
Contribute to 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.
Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
Assist with investigator meeting coordination and planning.
Required Qualifications and Background
Degree in a relevant discipline with experience in the Clinical Trial environment required.
Knowledge of ICH/GCP and regulatory guidelines/directives.
Demonstrates analytical approach and anticipation of problems.
Identifies gaps and provides constructive feedback and solutions.
Ability to multi-task effectively and prioritize assignments from multiple sources.
Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments.
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 looks for ways to contribute.
Basic understanding of project management desired.
Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
Strong oral and written skills with proficiency in English.
Excellent organizational skills
Physical Demands / Travel
This position may require up to 25% travel. Some of the travel may be international.
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 based in the field and in a typical office setting.
The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.
- To perform this job successfully, an individual must be able to perform each roles 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.