Senior Clinical Project Manager

** Remote in the Northeastern US**

Pay: $150,000 - $175,00 +Bonus

With a workforce of more than 3500 employees spread across Ireland, United Kingdom, Mainland Europe, MENA, and the USA, Uniphar is a trusted global partner to pharma and Med Tech manufacturers, working to improve patient access to medicines around the world. Uniphar provides outsourced and specialized services to its clients, leveraging strong relationships with 200+ of the world’s best-known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our highly expert teams.

Uniphar is organized into three key divisions:
Supply Chain & Retail, Global Sourcing, and Pharma. This position will support human resources across the US division.

to find out more:
About Us - Who we are | Uniphar

Uniphar is a combination of many businesses each with their own identity, culture, values, and ways of working. Uniphar lives and breathes four key pillars which unpin and support our culture.

We have a people first approach - we do the right thing. We support an entrepreneurial spirit where adaptability, commitment & resilience is embodied in our way of working. We have a Common Purpose that connects our diversified businesses and people. Finally, Trust is at the heart of how we operate.

Everything Uniphar does is enabled by our people, and, as we continue to grow domestically and internationally, we become more diverse. This diversity fuels our business and culture.

Sustainability is at the core of what we do and is deeply embedded in our business strategy. We want to contribute positively to the people and the world around us. Running our business in a sustainable way ensures that Uniphar will continue to prosper in the long-term. We are focused on ensuring that each of the five pillars of our sustainability strategy are a fundamental part of our decision-making process.

The Senior Clinical Project Manager (Sr CPM) will be responsible for the overall execution of clinical operations activities on behalf of Uniphar Development Partners for trials spanning Phase I through Phase Ill.

The Sr CPM serves as the primary contact to Contract Research Organizations (CROs), Service Providers, site investigators, study personnel, as well as internal Uniphar Development functional areas, the Product Development Team (PDT) members, and the Partner to relay trial progress, status and/or issues associated with the daily operations of one or more clinical trials. The Sr CPM will be responsible for all aspects of the clinical trial from pre-study planning, protocol review, management of CRO(s) and other ’Service Providers, through clinical study report finalization for regulatory submission.

The Sr CPM will ensure trial conductivity follows ICH-GCP, FDA/EMA, or other regulatory health authorities, and Standard Operating Procedures (SOPs), as applicable. The Sr CPM will also ensure all operational trial deliverables are met according to project agreement(s), timelines, budget, operational procedures, and quality standards.

• Manages all study-related activities to meet defined study timelines, stated goals, budgets, while ensuring GCP/ICH guidelines and the relevant SOPs are met

• Responsible for vendor management as related to the study, in particular, oversight of CRO activities related to conduct of clinical studies

• Leads internal study team meeting with functional area representatives

• Responsible for leading and coordinating the development of study-related documents such as Clinical Project Plans, Informed Consent, Case Report Forms (CRFs), Monitoring Plan, Patient Diary, CRF Completion Guidelines, Safety Management Plans, Communication Plans, Clinical Study Quality Plans, and other relevant study plans and charters

• Maintains primary responsibility for the content of all study-related operational manuals, such as study operations manuals, pharmacy manual, and Service Provider manuals

• Oversees investigator recruitment/selection and the conduct of trials at investigative sites

• Participate as necessary in monitoring visits (co-monitoring), reviews monitoring visit reports and letters, and ensures CRO quality within trials

• Plans, executes, and leads Investigators’ Meetings, if applicable; or may lead Site Initiation Visits, Clinical Research Associate (CRA)/Monitor training, and/or any other study related training

• Tracks study progress ensuring timely data…