R&D Partners is seeking to hire a Clinical Study Lead in Little Falls, NJ

Your main responsibilities as a Study Lead

• Provide leadership for one or more global Study Management Teams responsible for delivering internally managed as well as outsourced First in Man thru Proof of Concept (Phase I) studies
• Accountable for the strategic and tactical study activities, ensuring high quality execution standards within the agreed budget and timelines
• Drive study strategy by designing study strategy, integrating the patient voice, driving diversity in enrollment, reviewing/contributing and evaluating executability of study protocol, country selection and data delivery plan, in partnership with cross-functional stakeholders; may be asked to contribute to the strategic development plans occasionally
• Lead study teams by providing the operational expertise and thought leadership as a leader of study teams that are accountable for delivering clinical studies; creating and driving study timelines, milestones and budget
• Manage risk and compliance by identifying, managing, and mitigating risks and issues while ensuring the study team is trained on and adheres to all appropriate standards, including ICH/GCP, SOPs and other regulations
• Mange vendor performance by providing direction and oversight for outsourced activities to ensure CRO and vendor delivery against contracted scope of work
• Innovative and Champion Change by driving process improvement, implementing new technologies and participating in supplemental non-project work e.g., participate in cross-functional initiatives, attend, and participate in conferences, ad boards

What we are looking for in a TITLE

• Bachelor s Degree
• 8-10+ years of Clinical Project Management experience
• Experience managing Phase I clinical trials
• CRO oversight

Pay Scale:

$76-$95 (Dependent on Experience)

R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal opportunity employer.