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. 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.
Essential Functions:
DCT study oversight and management.
Ensures timely operationalization of each project plan, by setting priorities for each study team member in accordance with project plans, ProPharma Group Standard Operational Procedures (SOPs), ICH/GCP guidelines and all regulatory guidelines.
Main point of contact for all issue escalation (Site, Sponsor, Vendors, GoClinical Project Coordinators (GCPC) and GoClinical Clinician Managers (GCCM).
Creates study-specific documents and training and submits to Sponsor for approval.
Oversees site setup including DCV introduction and training.
Develops and delivers protocol specific training and applicable amendment training to GoClinical Clinicians (GCCs), GCCMs, and GCPCs.
Sets up and maintains necessary vendors for each study (e.g., central pharmacy, central lab, equipment).
Organizes and leads Sponsor/CRO, Central Lab and Vendor teleconferences.
Tracks objectives and key performance indicators related to all Decentralized Visits.
Manages monthly unit trackers, invoices, and GCC payments.
Provides guidance to GCPCs and GCCs assigned to projects.
Complies with Quality Management System and applicable SOPs.
Escalates risk and risk mitigation plans for all study related issues to Associate Director, DCT or designee.
Communication to all study teams and management of study closeout.
Other duties as assigned.
Necessary Skills and Abilities:
Current knowledge of and the ability to apply ICH/GCP and all applicable regulations and guidelines.
Proven track record of independent execution of successful studies (delivered on time, within budget, and with high quality) from startup to closeout.
Competent in application of standard business procedures (SOPs, Global Regulations, OEC, and Outsourcing).
Well organized and able to multi-task.
Positive and energetic attitude towards all aspects of the role including leadership of study team.
Professional, well spoken, and articulate.
Management of study team, mentoring, oversight, providing issue escalation, and resolution.
Educational Requirements:
Bachelor’s Degree or equivalent experience defined as a minimum of 5 years related, combined experience in education, knowledge, and skills that will enable the incumbent to perform the tasks of the role proficiently.
Experience Requirements:
A minimum of 2 years of direct clinical research experience including experience in managing and completing clinical trials from pre-study activities through study completion and data summarization.
Phase II or Phase III, global experience, and experience in multiple therapeutic areas or disease state/indications desirable.
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.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
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