Sr. Clinical Trial Leader (Canada)

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Senior Clinical Trial Leader (Sr. CTL) to join our A-team (hybrid*/remote). As a Sr. CTL at Allucent, you are responsible for providing 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.

In this role, your key tasks will include:

• 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.
• Oversight of critical documentation collection, maintenance and filing.
• Developing the Monitoring Plan and site monitoring templates and tools as well as providing input into Trial plans & tools.
• Reviewing trial-specific documents upon request as well as developing or reviewing subject-facing materials.
• Customizing 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, resolution and escalation.
• Working with PM and/or patient recruitment manager to support project recruitment timelines and site recruitment plan.
• Managing successful trial close-out, identifying critical activities to make timely and efficient close-out.
• Responsible for timelines, budget and quality of Clinical Monitoring team deliverables, identification of risks and issues and escalation to PM, Line Manager, and GCO management.
• Providing information and input about planned activities and status to PM and attending Project Review Meetings if/when needed.
• Conducting project co-monitoring if required and temporarily conducting site management/monitoring in case of immediate need.
• Coaching/mentoring CRA team including providing performance feedback as appropriate.
• Preparing and chairing CRA calls and actively participating in internal trial team calls and client calls.
• Overseeing/attending CRA handovers as appropriate.
• Serving as a site contact for protocol clarifications and subject enrolment if CRA unavailable.
• Monitoring and managing trial materials supplies ensuring Investigational Product and other trial supplies are shipped to sites.
• Reviewing data listings and query reports to identify trends and ensuring proactive re-training is conducted with CRAs and site staff.
• Overseeing the process of protocol deviation and Trial non-compliance documentation, tracking and escalation.
• Participating in the development of trial newsletters communication.
• Requesting appropriate Clinical Operations staffing, workload and resources and reporting trial deliverables and resource needs.
• Assisting the PM in discussions with clients on trial documentation issues or technical related documentation concerns.
• Reviewing trial systems (CTMS, CRF, IRS, central lab portal, etc.) updates on regular basis.
• Overseeing eTMF status.
• Reviewing trial reports and analyzing trends to recognize risks, providing input into mitigation plans.
• Contributing to optimization of trial processes to increase efficiency.
• Coordinating and providing support for trial related audits & inspections.
• Contributing to corrective and preventive action plans where needed and ensuring their timely implementation and closure.
• Ensuring project consistency within and across projects by following Allucent/relevant SOPs.
• Assisting and supporting in the preparation of various training material used by Allucent.
• Assisting in the preparation and conduct of Kick-Off Meetings, Investigators’ meetings and other committees’ or Trial meetings as requested.
• Preparing Country Level Site Facing Budgets and managing Investigator and Site Payments as applicable.
• Supporting PM in the management of trial vendors as required.
• Managing client expectations related to Clinical deliverables in accordance with contracted services and Allucent QMS.
• Providing input into proposals when required.
• Actively participating in the preparation, attendance and presentation of bid defenses or any other presentations to potential clients.
• Completing routine administrative tasks in a timely manner (e.g. timesheets, travel expense claims, training).
• Other responsibilities as required.

To be successful you will possess:

• Candidate must be legally authorized to work in the specified Country where job is being advertised.
• A degree in life sciences or nursing qualification preferred, but not required.
• A minimum of 5 years clinical research experience (including a combination of SCRA + CTL/CTM, PM or Regulatory/Auditing experience) with at least 1-2+ years CTL/CTM experience.
• In-depth knowledge of ICH GCP, clinical trials and the critical elements for success in clinical trials.
• Strong therapeutic background.
• Experience and knowledge in the CRO industry that will support Allucent’s management of clinical trials.
• Strong written and verbal communication skills including good command of English language.
• Professional and strong client focused.
• Ability to work in a fast-paced challenging environment of a growing company.
• Administrative excellence with attention to detail and accuracy.
• Leadership and mentoring skills with ability to mentor and train other CRAs in a positive and effective manner.
• Excellent team player with team building skills.
• Strong organizational skills to manage a full workload across multiple projects.
• Demonstrates flexibility for creating solutions and process improvement.
• Analytical, financial and problem resolution skills.
• Proficiency with various computer applications such as Word, Excel, and PowerPoint, CTMS, eTMF required.
• Ability to successfully manage people/project issues.
• Mature management skills demonstrated by calm and thorough review of situations.
• Seeks to understand all contributing factors.
• Proposes, implements, and evaluates appropriate, creative resolutions.
• Demonstrates the ability to define and meet project requirements.

Benefits of working at Allucent include:

• Comprehensive benefits package per location.
• Competitive salaries per location.
• Departmental Study/Training Budget for furthering professional development.
• Flexible Working hours (within reason).
• Opportunity for remote/hybrid working depending on location.
• Leadership and mentoring opportunities.
• Participation in our Buddy Program as a new or existing employee.
• Internal growth opportunities and career progression.
• Financially rewarding internal employee referral program.
• Access to online soft-skills and technical training via GoodHabitz and internal platforms.

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-Remote #LI-DF1