Study Start Up Specialist (FSP)

Parexel International Corporation

Denmark, Remote

Position Purpose:The Study Start Up Specialist is an in-house position responsible for supporting site start-up activities, including collection and review of essential documents, and reviewing and approving Informed Consent Forms (ICFs) for ethics committee submissions for assigned clinical sites.

Primary Responsibilities:

  • Accountable for site start-up for assigned clinical sites.

  • Serves as site’s primary point of contact for start-up, resolving site queries and assisting sites with ethics committee submissions.

  • Sends start-up packets.

  • Reviews and approves ICFs pre- and post-ethics committee submission.

  • Collects, reviews, approves, and tracks essential documents, and reviews and approves ICFs in accordance with Seagen processes and timelines.

  • Assists in resolution of site queries for assigned clinical sites.

  • Provides regular updates and escalates site issues to Manager, SSU.

  • May attend weekly start-up meetings with Manager, SSU, Protocol Lead (PL), Clinical Contracts Manager (CCM), Legal, and other key stakeholders as necessary.

  • Forecasts and tracks metrics and progress of site start up for assigned clinical sites, ensuring all sites are greenlit on time per study start-up timelines.

  • Ensures metrics in clinical trial management systems are up to date and accurate.

  • Ensures site essential documents are uploaded to electronic Trial Master File (eTMF) accurately and on time for site greenlight.

  • Prepares greenlight packets for assigned clinical sites.

  • Performs second review of essential documents and/or ICFs for other members of the Study Start Up Team.

  • Mentors junior Study Start Up Team members.

  • Manages time on assigned clinical sites across one or more clinical studies and escalates issues to Managers, SSU.

  • Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system/process related training.

  • Adhere to EP and Client SOPs and processes.

The Individual:

  • Bachelor of Arts or Science (BA/BS) or equivalent or any relevant and qualifying training.

  • Minimum of 3 years of relevant clinical trial experience.

  • Minimum of 3-5 years of pharmaceutical or biotechnology industry, preferred.

  • Thorough knowledge of clinical start-up process and requirements required.

  • Knowledge of CFR and ICH/GCP requirements is required.

  • Requires effective organizational and time management skills.

  • Able to multi-task under limited direction and on own initiative.

  • Strong communication and inter-personal skills.

  • Highly responsive and proactive, a team player.

  • Previous start-up unit experience, preferred.

  • Oncology clinical research experience, preferred.

  • Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint.

  • Proficiency in written and spoken English


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