Clinical Trial Leader - Cary, United States - Allucent

Description

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 Clinical Trial Leader (CTL) to join our A-team (hybrid*/remote). As a 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, including: Managing 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 as well as providing input into Trial plans & tools.

+ Review trial-specific documents upon request as well as develops or reviews subject-facing materials. (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, resolution and escalation.

+ Where applicable, works with PM and / or patient recruitment manager to support the project recruitment timelines and (site) recruitment plan as well guiding the CRA team

+ Manages successful trial close-out, identifies 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 .

+ Provides information and input about planned activities and status to PM and attends Project Review Meetings if/when needed.

+ Conducts project co-monitoring (if required) & if needed temporarily conducts site management / monitoring in case of immediate need and lack of resources.

+ Coaches/mentors CRA team including providing performance feedback as appropriate, assisting in developing and delivering project-specific training and providing input related to Project Specific Training Matrix.

+ Prepares and chairs CRA calls and actively participates in internal trial team calls and client calls.

+ Oversees / attends CRA handovers as appropriate.

+ Serves as a site contact for protocol clarifications and subject enrolment if CRA unavailable.

+ Monitors and manages trial materials supplies ensuring Investigational Product and other trial supplies are shipped to sites.

+ Reviews data listings and query reports to identify trends and ensures proactive re-training is conducted with CRAs and site staff.

+ 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.

+ Assists, where appropriate, the PM in discussions with clients on trial documentation issues or technical related documentation concerns that may arise.

+ 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.

+ Oversees eTMF status.

+ Reviews trial reports and analyzes trends to recognize risks, provides input into mitigation plans and implements mitigations belonging to clinical activities

+ Contributes to optimization of trial processes to increase efficiency

+ Coordinates and provides support for trial related (site) audits & inspections

+ Contributes to corrective and preventive action plans where needed and ensures their timely implementation and closure

+ Ensures project consistency within and across projects by following Allucent / relevant SOPs.

+ Assists and supports in the preparation of various training material used by Allucent (including SOPs training, as well as specific trial related).

+ Assists in the preparation and conduct of Kick-Off Meetings, Investigators meetings and other committees or Trial meetings as requested.

+ Prepares Country Level Site Facing Budgets and manages Investigator and Site Payments as applicable.

+ 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

+ Manages client expectations related to Clinical deliverables in accordance with contracted services and Allucent QMS.

+ Provides input into proposals when required.

+ Actively participates in the preparation, attendance and presentation of bid defenses or any other presentations to potential clients

+ Complete routine administrative tasks in a timely manner (e.g. timesheets, travel expense claims, training)

+ Other responsibilities as required.

Requirements

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 years CTL/CTM experience (depending on selected level CTL / Sr. CTL)

+ In-depth knowledge of ICH GCP, clinical trials and the critical elements for success in clinical trials

+ Strong therapeutic background

+ Possesses experience and knowledge in the CRO industry that will support Allucents management of clinical trials Skills

+ 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 be able 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

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. 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.

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