Planet Pharma is partnering with a pharmaceutical client seeking to hire a Senior Project Manager to oversee the setup, execution, and management of Expanded Access Programs (EAP) and Post-Approval Named Patient Programs (PA-NPP).
Key Responsibilities:
* Manage the start-up, execution, and close-out of regional and global projects in line with clients SOPs and policies.
* Create and maintain project plans, ensuring timelines and budgets are met, and track changes through Change Orders.
* Lead and support project teams, providing guidance, training, and oversight.
* Build strong relationships with clients and act as their main point of contact.
* Identify and manage project risks, keeping internal teams, management, and clients informed.
* Join proposal meetings and help Business Development with contracts and new opportunities.
* Help develop and update internal processes to ensure consistency across projects.
* Manage direct reports, including training, development, and performance reviews.
* Oversee the completion and accuracy of the eTMF and CTMS systems.
* Stay informed on US, UK, and EU regulations, as well as GxP and ICH guidelines related to EAP, PA-NPP, and clinical research.
Key Requirements:
* Bachelor's Degree (Health or Science field preferred)
* 4+ years of project management or clinical research experience, preferably in a CRO setting
* Minimum of 2 years' experience in monitoring and managing clinical research projects
* Proficiency in Microsoft Office
* Ability to travel up to 20% of the time
* Strong organizational skills and attention to detail
* Excellent verbal and written communication skills
* Demonstrated leadership and management abilities
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
Please click ‘apply’ or contact Charlotte Fagan (Recruitment Manager) at Planet Pharma for more information:
E: cfagan@planet-pharma.co.uk
T: +442070764110