17 Oct
ProPharma Group
London
Job description
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies.
As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.
With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D; technology,
ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
We're looking for a Clinical Project Manager to support ProPharma in providing strategic and tactical operational planning and execution on a number of upcoming studies.
You will be responsible for oversight and conduct of clinical research trials, ensuring they are executed in accordance with applicable regulations and that the quality of clinical data generated meets the requirements for Regulatory Authority approval.
This role is offered on a fully remote, full time, permanent basis.
Key Responsibilities :
Plans and manages assigned studies from start to close out.
Managing project timelines and project budget.
Proactively anticipates and understands concerns / issues / delays
Develops risk assessments and contingency plans.
Holds each functional area responsible for associated risk mitigation and management.
Primary source of communication for the clinical project team,
cross functional project teams and internal and external stakeholders.
Participates in project kick-off meetings.
Provides regular updates to client and manages communication between team members and client.
Monitors project budget vs. cost. and ensures project margins are met.
Provide study-specific training for clinical operations staff as appropriate.
Evaluate and identify resourcing needs and monitor over life cycle of the study.
Develop, analyze and report study metrics to Sponsor per Project Plan and proactively identify and communicate any risks or concerns.
Develop and maintain Study Project Plans.
Provide strategic input into study documents.
Manages study drug product and non-drug site supplies.
Develops the agenda and manages the planning and execution of Investigator Meetings.
Responsible for the development and presentation of slides and training materials for various audiences.
Assists with vendor selection (ECG, Lab, IWRS, IRB, Raters) and contracting.
Ensures clinical study team compliance with applicable FDA / ex-US regulations, ICH-GCPs, other local regulatory requirements and corporate SOPs.
Develop subject recruitment / retention strategy and related initiatives for assigned studies.
Oversee maintenance and quality review of study TMF.
Qualified Candidates Will Have :
Relevant Bachelor’s degree or advanced degree (e.g., Master, PharmD, PhD). Candidates with equivalent combination of education, training, and experience will be considered.
Several years clinical trial and research experience.
Knowledge of FDA and / or ex-US Regulations, ICH Guidelines, and
GCPs governing the conduct of clinical trials.
Experience managing / mentoring and developing junior staff.
Demonstrated experience in change management initiatives.
This role sits within our Clinical Operations Team. You can find out more about them and what they do here :
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion.
Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer,
we provide a safe space where all employees feel empowered to succeed.
ProPharma Group does not accept unsolicited resumes from recruiters / third parties. Please, no phone calls or emails to anyone regarding this posting.
▶️ Clinical Project Manager
🖊️ ProPharma Group
📍 London