PRA Health Sciences
US National – Telecommute
Independent Drug Monitoring Manager (Home-Based)
Job Locations: (All) | US-Remote
We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you’re ready to be a part of something inspiring join us and Discover Your PRA.
Who are we?
We Are PRA.
We are 16,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
What will you be doing?
Supports the execution of clinical trials in the area of unblinded drug management. Responsible for the general facilitation of the Independent Drug Monitoring process between the IDM Team and the study team.
Lead study teams in management of CROs for IDM process; including (input to) the development of pharmacy related materials (e.g, forms and manuals) and system set-up (e.g, IVRS and EDC).
Resolve and document urgent/critical unblinded and pharmacy related issues and investigate trends (IDM)
Ensure existence and accuracy of relevant IDM process documentation, communication and monitoring plans
Ensure adherence to timelines and quality of the IDM process and follow up with vendors appropriately to resolve any issues
Act as the main point of contact for resolution of any ad-hoc questions associated with IDM issues
Provide input to refine GCO IDM process in alignment with stakeholder needs and in compliance with systems, and strategies by identifying innovative process improvements, determining feasibility, and collaborating with appropriate parties to implement when appropriate
Work proactively to increase global awareness of IDM processes and train and educate stakeholders
Work closely with stakeholders that are globally located
Contribute to ensuring optimum utilization of resources and compliance with project deadlines for IDM
Oversees all (Lead) IDM activities
Reviews IDM monitoring visit reports (initiation, periodic & close-out) (defined %)
Monitors status and resolution of major/critical issues via Issue logs and visit report review process
Translates, documents and escalates major/critical issues to GTM and the trial’s medical monitor in a blinded manner
Provide inputs in audit CAPAs
Assist in database locks in reviewing unblinded queries (if needed)
Provides updates to GTM on pharmacy-related and compliance issues in a blinded fashion
Ensures training is provided to the (Lead) IDMs and staff involved in the management of TTs.
Potential of Co-monitoring of IDMs and Lead IDM
Potential for Management of day-to-day operational support of IDM
Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by GCO management as well as R&D companies, corporate, HCC and QA guidelines
This is not an exhaustive, comprehensive listing of job functions and tasks. Other duties may be performed as assigned.
What do you need to have?
University or Bachelor’s degree or equivalent in appropriate scientific or business disciplines.
Candidate is required to have at least 5 years of experience in clinical trial operations.
Fluency in English.
Experience in project management and/or logistics is mandatory.
Must demonstrate innovative spirit, strong interpersonal and leadership skills and complex project management.
Knowledge of databases and/or project management systems is also a plus.
Previous work in an international environment desirable.
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment…
Medical & Health , Medical Research , Pharmaceutical