Study Start Up Specialist

Site Start-Up Packages

• In cooperation with Project Management create study-specific start-up document package.
• Distribute and follow up with sites to obtain the required executed documents.
• Review content and correctness of returned documents from the sites, in accordance with internal standards.
• In conjunction with Regulatory Affairs, ensure that the correct and complete packages are obtained within the planned timelines.

Site Contract and Budget Negotiation

• In co-operation with Contract and Legal, obtain feedback on suggested site and investigator contract language.
• Act as main point of contact for sites to obtain feedback on budget and contract negotiations.
• In conjunction with the Project Manager, provide sites with the suggested study budget and negotiate within pre-approved margins.

Site Intelligence Tracking

• Maintain site intelligence tracker with data related to specific requirements for study sites such as start-up timelines, budget, contract negotiation timelines and prerequisites, patient recruitment data, etc.
• Provide input for suggested site list during start-up using past experiences with potential study sites.

Site Start-Up Planning and Tracking & Project Management support

• Act as main contact for study sites during start-up.
• Develop and maintain relationships with study sites that will facilitate timely completion of start-up.
• In conjunction with project management and CRAs, plan start-up actions and provide expected SIV dates for individual sites based on previous start-up metrics, as well as regulatory and /RB timelines.
• Track progress of start-up activities in smart sheet and/or CTMS.
• Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentations.
• Provide support to project management with study related activities as required.

Qualifications

• Applicants should have a minimum of one to three years of related work experience with ongoing training, or a minimum of a one-year College Advance Diploma/Degree in a relevant field of study, preferable in Health or Life Sciences, or Clinical Research. The successful candidate must exhibit the following skills: Excellent communication skills. Knowledge of start-up requirements for clinical sites. Experience in working directly with clinical study sites through previous involvement in studies. Very high sense of urgency.
• Proficient in both Italian and English.

Working Conditions

• Home-based

Originally posted on Himalayas