Associate Project Manager Clinical Pharmacology

ZipRecruiter; Leeds; Hybrid; GBP 30,000 - 60,000; Full time

Job description

Job Description

What if your project management skills are what we need to fast-track safety decisions for new patient medicines? Fortrea is one of the largest early-stage drug development organizations in the world. We help our biopharma customers bring new medicines to patients in need. From first-in-human to exploratory biomarker or complex Phase 1b trials, in our clinical pharmacology team we generate critical data that set the future of investigational drugs...

Much of the data you will work with will end up in a drug’s label! This is a remote job, anywhere in the UK. Miss some office time? Hybrid options if you live close to our Leeds Clinical Research Unit.

YOUR MISSION

Our Clinical Pharmacology Services team is being entrusted with delivering more sophisticated study protocols, moving towards bigger, multi-country/multi-center studies. By joining Fortrea as an Associate Project Manager, you´ll be making your first step in an exciting PM career journey, one that will take you to oversee global clinical trials. In this job, you will start overseeing low-complexity clinical trials, which are executed in our own Clinical Research Unit in Leeds (with a capacity of 100 beds), designed for Healthy Volunteers, and include labelling, bioequivalence, and bioavailability study types.

WHAT YOU WILL DO DAY TO DAY

As our Associate PM, your impact will be clear from day 1:

1. Act as a single point of contact and escalation for the client, overseeing timelines, scope, budget, risk, driving issue resolution and internal and client communications.
2. Run sponsor meetings, from initial kick-off to ongoing weekly meetings to cover status, issues, risks, etc.
3. Drive Cross-Functional teamwork success: oversee and foster collaboration across teams (Data Management, Medical Writing, Statistical Programming, Start-up, Project Coordinators, Document & TMF specialists) while ensuring scientific integrity and human subject safety.
4. Implement and monitor progress against project plans.
5. Overall management of the project timelines, ensuring that changes or updates are made and communicated timely.
6. Renegotiate timelines with the client and project team and implement risk mitigation strategies.
7. Identify work scope changes against the project and initiate & develop change orders.
8. Accountable for TMFs including TMF Index & Plan, audit readiness and delivery of TMF per agreed timelines.
9. Assist in the development of project-specific training, ensuring project team members have read, reviewed, and documented project-related documents and plans.

At the end of your first year, success would mean you will start managing more complex projects (i.e. Dose Escalation, Impairment), teams, and operations involving our other clinics in the US and/or external sites.

WHO YOU ARE

Since this is a highly specialized job in Clinical Pharmacology, these are must-have skills we need you to bring:

1. Phase I experience: proven track-record work in early-phase trials is key.
2. You are used to the Healthy Volunteer space and its fast-paced environment.
3. Extensive clinical research expertise in a CRO or biopharmaceutical company.
4. Previous experience that may prepare you for this job: Clinical Team Lead, Sr. CRA, Sr. Start-up Specialist, Experienced Study Coordinators.

Beneficial: Veeva and MS Project.

Education/Qualifications: University/college degree in life science.

WHY US?

We are 15,000+ people around the world, but there is a family feel to our teams. Here, you will find support, structured processes and colleagues who take great care each one of us has what we need to do our job. Join the Early Clinical team at Fortrea and let´s advance medical science together.

#LI-CV1 #LI-Remote #LI-Hybrid Learn more about our EEO & Accommodations request here.