Specialist, Clinical Operations

Job Description

Our company is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Our Research Laboratories are a true scientific research facility of tomorrow, and will take our leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Global Site Agreements (GSA) is a Research Laboratories organization that drafts, negotiates, and executes agreements on a global basis. We are responsible for negotiating industry sponsored clinical trial agreements, confidentiality agreements, and other type of agreements related to clinical research.

As a GSA Specialist you will work closely with experienced GSA team to:

• Review, escalate and stamp site CTRA and other type of the site agreements (e.g.MCTRA, FUA, CSA, UDPD, DOA for both in- and outsourced trials.); and/or draft, negotiate, and execute scientific input Consulting Agreements and Investigator Studies Program (MISP) agreements

• Act as liaison to Office of General Counsel, Privacy, Compliance and Clinical Teams, as appropriate,to resolve contractual/legal issues with sites, investigators, and consultants

• Maintain high level of collaboration and interaction with the GCTO Country Operations/division Functional area and act as a liaison with Global Operations

• Participate in regional and global improvement projects, identify and propose improvements to the internal systems or processes to ensure high compliance and efficiency standards

• Support appropriate GCTO region/division functional area meetings and trainings to ensure understanding of contracting process

• Support departmental initiatives including filing, metric reporting and quality control

Education Minimum Requirements:

• Bachelor's Degree

Required Experience and Skills:

• Minimum of 5 years of relevent experience in pharmaceutical industry

• Superior communication, presentation and writing skills

• Excellent analytical ability

• Good team player and ability to work independently in a global setting

• Microsoft Office and data analytics proficiency

Preferred Experience and Skills:

• Prior work experience in contracting/budgeting in clinical research setting

• Good Clinical Practice Certificate

• Project Management Skills

Location Note: If someone lives within 50 miles of Upper Gwynedd, PA location, would like to have them as a hybrid employee per company policy. Remote candidates outside this area will also be considered.

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ResearchandDevelopmentGCTO

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