- Manage or assist in managing study execution, including management and oversight of CROs, vendors and consultants that are involved with the clinical trial.
- Contribute/establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Proactively identify risks, offer mitigation strategies and support implementation
- Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.
- May oversee investigator recruitment/ selection across project
- Participate in ad hoc clinical operations’ initiatives and programs.
- Contribute to preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates.
- Contributes to the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, project management plans, communication plans, and quality plans
- Oversight of clinical monitoring to ensure that all outstanding site issues are closed out in a timely manner (if applicable).
- Participate in the forecasting of Investigational Medicinal Product and clinical trial related supplies.
- Tracks study progress ensuring timely data collection, monitoring and, in collaboration with data management, internal listings reviews
- Ensure that the Trial Master File (TMF) is set up and maintained throughout the trial in compliance with ICH/GCP and company SOPs, including conducting periodic risk based reviews to ensure all appropriate documents are filed.
- Assist with the development of the clinical components of regulatory submissions including, but not limited to safety, interim and final study reports.
- Participate/provide assistance with responding to Quality Assurance audits and/or regulatory authority inspections
- Assist with ongoing study communication and escalation of study-related issues as required.
- Participates in meetings with investigator sites, key opinion leaders and consultants as needed.
- Facilitate the development of clinical trial agreements and other relevant documents.
- Contribute to request, creation and review of scope of work and budgets; participate in vendor performance management and issue resolution.
- Review and provide input for site budgets, manage clinical trial budget, providing ongoing financial reporting and projections to finance.
- Reconciliation and reporting for vendor and site invoices, payments and change orders, ensuring accuracy and timely delivery
- Work cross-functionally to ensure clinical program timelines and goals are met.
- May participate in site visits, evaluating CROs/contract monitors through co-monitoring visits and/or site audits
- May provide study-specific mentoring for junior team members, as appropriate.
- Participate in operational improvement initiatives (e.g. SOP development, training, etc.).
- Bachelor’s degree in health sciences or related field.
Experience and Skill Requirements:
- Minimum of 5+ years’ experience in clinical research with at least 2 years’ experience in study management. Clinical Monitoring preferred.
- Experience in management of CROs, vendors and consultants.
- Documented training, knowledge and application of current FDA Regulations, ICH-GCP guidelines for clinical trials required.
- Proficient written and verbal communication skills.
- Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
- Therapeutic (oncology) or medical knowledge preferred.
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
- Position may require some travel.
EEO & Employment Eligibility
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.
Replimune now requires Covid vaccination disclosure for all US employees.