Clinical Trial Associate

Clinical Trial Associate

At Mindlance, we strive to deliver value through the combination of right people, processes, technologies and program management solutions. Our methods include applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective.

All in all, our expertise lies in providing trained and committed minds to help meet your business objectives, irrespective of the stage your business is in.

Job Title:

Clinical Trials Disclosure Associate Duration: 1 year+

Location:

Woodcliff Lake, NJ

JOB DESCRIPTION:

The Clinical Disclosure Associate will work across multiple disciplines within and outside Regulatory Affairs to drive departmental and project objectives. Person will be responsible for coordinating the posting of registration and disclosures on clinical trials.gov, EudraCT and other registries for company-wide studies. This comprises supervision of the vendor as well as coordination of company internal processes to ensure compliance with all relevant legal obligations (primarily clinical trials.gov

and EudraCT disclosure). Must be database proficient with registrations and disclosures. Has the ability to work cross-functionally and meet required deadlines. Ensures trial disclosure is in compliance with applicable regulations globally. Develops and maintains strong internal relationships across all levels of the clinical organization. Escalates issues to management in an expedient manner. Continually train and remain in compliance with all current industry requirements as they relate to clinical trial disclosures.

On occasion, responsibilities may be extended to:

• reviews of clinical and regulatory documents and regulatory submissions for data accuracy, consistency, formal quality and readability, resolving identified issues in collaboration with authors in a productive fashion
• Coordinates all Client clinical disclosure activities, acting as primary intermediary between the disclosure vendor and Client contacts
• Works with Client contacts to identify and resolve compliance gaps
• Supports continual improvements by evaluating disclosure business process, suggests and implements improvements to enhance compliance, documents processes and trains relevant personnel
• Maintains Client disclosure trackers and produces metrics reports for management
• Maintains Client product information for use in disclosure activities

REQUIREMENTS:
Bachelor's degree required. At least 3 years working in the pharmaceutical industry in an R&D environment. Solid knowledge of clinical trial transparency principles, preferably on an international level Strong attention to detail and the ability to work as a part of a team across multiple departments Strong communication and influencing skills.