Clinical Trial Leader / Sr. Clinical Trial Leader
Allucent, United States
Job Description
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.
These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in patients’ lives.
We are looking for an experienced Clinical Trial Leader / Senior Clinical Trial Leader
The Clinical Trial Leader (CTL) provides leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial activities on a global, multi-country, or regional basis. The CTL is responsible for coordinating and managing the planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract, budget, timelines and with quality. The CTL serves as a proactive member of the core project team, liaising closely with the Project Manager (PM) and other department leaders if /when necessary on all trial-related issues and service delivery. The CTL will perform tasks with minimal supervision whilst assisting, mentoring, and supporting the CRA teams. The CTL may support the management team with training, process improvements, co-monitoring visits, mentoring of staff and / or any other special assignments within Global Clinical Operations.
This is a full-time, direct hire opportunity for an experienced Trial Leader residing in the US or Canada. Ideal candidates should have a combination of SCRA + CTL/CTM or Regulatory/Auditing industry experience providing oversight to Oncology, Infectious Diseases and/or Vaccine clinical trials.
Location: Hybrid OR Remote role (depending on candidate location) in US or Canada
This position will be hybrid for those living near one of our office locations, however, for those further in distance the role can be offered remotely. Strong English Communication (written and verbal) is required.
Travel: On rare occasions where travel is needed, may require 10% travel to attend bid defense meetings, company visits, possible audits, etc.
Preferred TA experience: Oncology, Infectious Diseases, Vaccines (Covid specific)
The CTL/ Sr. CTL will be responsible for the following tasks:
- Responsible for coordinating and managing CRA activities across all geographies, liaising with sponsor and Project Manager and other functional leads to ensure clinical monitoring deliverables (timeline, budget, quality, productivity) are met, including: • Manages the trial start up and site activation in collaboration with PM, Global Regulatory Lead and, if applicable, Global Site Activation Manager (GSAM).
- Oversight of critical documentation collection, maintenance and filing.
- Develop the Monitoring Plan and site monitoring templates and tools.
- Provide input into Trial plans and tools (e.g., protocol, Project Plan, Data Management Plan, eCRF Guidelines, TMF Plan, TMF Index, Risk Log, Recruitment Plan amp; trackers, Site Activation Management Plan, Regulatory and Ethics Submission Plan (RESP), Clinical Trial Agreement amp; Budget Plan (CTABP), Investigation Product Release Authorisation Plan (IPRAP), Trial Non-Compliance Management Plan, Medical Monitoring Plan, Safety Management Plan, Centralized Monitoring Plan, etc.)
- For trials with separate unblinded monitoring and when assigned unblinded CTL role, develops or assists the PM in the development of CRO Blinding Plan, Unblinding Plan and all necessary tools and templates for the unblinded monitoring and site activities.
- Reviews trial-specific documents upon request (e.g., Protocol, Subject Information Leaflet/Informed Consent Forms, Laboratory Manual, Pharmacy Manual)
- Develops or reviews subject-facing materials such as: Letter for the GP, Subject ID card, instructions for the subjects (if necessary)
- Customizes the annotated Site Visit Reports according to trial specific requirements.
- Selection of investigators and sites; SEV report review and approval.
- Site initiation management; SIV report review and approval
- Monitoring Visit Report (MVR) review, management, r