Job Description

Senior Study Manager

Remote - Canada

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Did you know?

Labcorp\'s Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea\xe2\x80\x99s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit .

Why settle for one thing when you can have everything? Fortrea gives you the best two for one opportunity for career growth. Who doesn\xe2\x80\x99t want twice the perks \xe2\x80\x93 working at one of the largest FSP CROs\xe2\x80\x94and partnering with one sponsor with a dedicated therapeutic focus.

Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global \xe2\x80\x93 extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.

We are seeking a Senior Study Manager to be responsible for operational deliverables including managing the Clinical Trial Team (CTT), supporting clinical supplies planning, site readiness, country allocation, and achievement of recruitment targets.

Additional responsibilities may include:

Operational POC for trial execution and deliverables

Manages and Leads Global CTT (Clinical Trial Team), supports clinical supply planning, and manages external vendors

Initiates planning for investigator meetings and protocol training

Plans and assesses protocol ancillary supplies

Completes trial set up and maintains CTMS

Initiates recruitment/retention and enrollment planning for protocols (globally)

Responsible for creating and maintaining project schedule and collaborating with Program Lead

Set up and maintain eTMF

Ensures alignment of budget with protocol needs and responsible for executing protocol within the budget

Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group

Manages Emergency Unblinding (EUB) Call Center activities

Oversees all HQ close-out tasks

Interface with External Data Coordination and Data Management

Responsible for creating and maintaining ADI logs

Responsible for risk assessment, mitigation, planning and all protocol plans

Responsible for end of study reconciliation globally (clinical & ancillary supplies)

Responsible for quality control and inspection readiness at all times

Requirements:

BS/BA/MS/PhD with 7+ years of clinical research experience

Minimum of 2 years\xe2\x80\x99 of pharmaceutical experience as a lead SM/PM required

Global trial experience required

Proven ability to meet aggressive timelines

Excellent MS Excel and PowerPoint skills

Excellent oral (including presentation) and written communication, database management, and project management skills

TA Experience Preferred

Preferred Experienced:

MS Project experience

Benefits: All job offers will be based on a candidate\xe2\x80\x99s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please .

#LI-Remote

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our .

Labcorp