Description
As Clinical Trial Leader, your role is essential to providing oversight to the Clinical Research Associates (CRAs) and other clinical functional groups within the study Team. You will play a major part in ensuring day-to-day clinical trial activities are being adhered to for assigned regional, global, and multi-country trials. You will be key in coordinating and managing the planning, implementation, tracking, and clinical deliverables according to protocol, ensuring budget, timelines and quality are met & maintained throughout study duration.
Being that this role may cover studies regionally & globally throughout the Americas, it's essential that you have experience managing US based trials and to be fluent in local language (Portuguese) as well as English - both written & verbally. 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.
About this role:
As a CTL, you are a member of our Clinical Trial Operations Team. You will be 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, timelines, budgets, quality, productivity and overall service delivery across all geographies. Within this role, you will perform tasks with minimal supervision whilst assisting, mentoring, and supporting the CRA's / study teams. At times, you might also support the management team with training, process improvements, co-monitoring visits, mentoring of staff and / or any other special assignments within Global Clinical Operations.
Your main responsibilities will include, but are not limited to the following:
- Manage the trial start up and site activation process through to close out activities in collaboration with cross functional team members.
- Oversight of critical documentation collection, maintenance and filing.
- Develop the Monitoring Plan and site monitoring templates and tools as well as providing input into Trial plans & tools.
- Customizes reports and other study related documentation & material according to trial specific requirements.
- Site & Investigator Selection, Initiation Management and report review & approvals.
- Monitoring Visit Report (MVR) review, management, resolution and escalation.
- 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 .
- Monitors and manages trial materials supplies ensuring Investigational Product and other trial supplies are shipped to sites.
- Oversees the process of protocol deviation and Trial non-compliance documentation, tracking and escalation.
- Participates in the development of trial newsletters communication.
- Requests appropriate Clinical Operations staffing, workload and resources and reports trial deliverables and resource needs.
- Reviews trial systems (CTMS, CRF, IRS, central lab portal, etc.) updates on regular basis, ensures systems reports are up to date and reports generated are current and correct as well as oversees TMF status.
- Coordinates and provides support for trial related (site) audits & inspections
- Assists in the preparation and conduct of Kick-Off Meetings, Investigators’ meetings and other committees’ or Trial meetings as requested.
- May provide input into proposals and actively participates in the preparation, attendance and presentation of bid defenses or any other presentations to potential clients
- Supports PM in the management of trial vendors as required.
- Project contract awareness and oversight; i.e.:
- Forecast and report on the site management units throughout project life cycle
- Identify changes in scope and liaise with the Project Manager
Requirements
About YOU:
You bring at least 5 years of clinical research industry experience having advanced from a Sr. CRA to a Trial Lead / Trial Management role overseeing study teams for local and global trials for at least 2+ years. To be successful we are looking for the following traits and behaviors:
- A degree in life sciences or nursing qualification preferred
- In-depth knowledge of ICH GCP, clinical trials and the critical elements for success in clinical trials
- Strong therapeutic background with knowledge of clinical systems (CTMS, eTMF) as well as proficiency with various computer applications such as Word, Excel, and PowerPoint, etc.
- Strong written and verbal communication skills including good command of English language
- Professional & client focused with ability to successfully manage multiple projects and be creative with solutions
- Ability to provide team oversight, mentor and train others in a positive and effective manner
About 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 unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.Together we SHINE.
Find more information about our values.
Benefits
Benefits of working at Allucent include:
- Comprehensive benefits and competitive salaries package per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Opportunity for remote/office-based* working depending on location
- Leadership and mentoring opportunities
- Participation in our enriching 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
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
- Eligibility for our SHINE Bright Award Program in recognition of demonstrating our SHINE values in action
Apply now!
If you meet the requirements to be successful in the role and are interested in being considered, please apply by clicking teh "Apply for this job" button below!
Disclaimers:
*Office-based employees are required to work in-office no less than two (2) days per each work week. There are certain positions for which employees are required to work in-office no less than three (3) days per each work 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. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”#LI-Remote #LI-DF1
