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Associate Manager, Study Start Up (FSP)

Parexel International Corporation

France, Remote

Position Purpose:The Associate Manager, Study Start Up is an in-house position responsible for site start-up activities and includes coordination, management, and oversight of site start-up for two or more clinical studies. This position includes indirect management of staff within the Study Start Up Team.

Primary Responsibilities:

  • Accountable for site start-up for 2 or more clinical studies.

  • Serves as primary point of contact (POC) and escalation for site start-up on assigned clinical studies.

  • Holds start-up Kick Off Meeting with Manager, Study Start Up, European Union (EU), Protocol Lead (PL), Clinical Contracts Manager (CCM), Legal, and other key stakeholders.

  • Holds weekly start-up meetings with Manager, SSU, EU, PL, CCM, Legal, and other key stakeholders as necessary.

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

  • Escalates site issues to appropriate Clinical Study Team members.

  • Attends Clinical Study Team Meetings through start-up.

  • Prepares and updates start-up packets for clinical studies

  • Assigns sites to Study Start Up Specialists, manages Study Start Up Specialist and Study Start Up Assistant workload for assigned studies.

  • Ensures Study Start Up Specialists collect, review, and track essential documents, and review informed consent forms (ICFs) in accordance with Client processes and timelines. Reviews greenlight packets and greenlighting sites.

  • Ensures Study Start Up Team members are properly trained on site start-up activities and kept current on timelines, contract/budget status, and study updates for assigned clinical studies.

  • May be responsible for sending start-up packets, review ICFs, collecting essential documents, and help sites with ethics committee submissions for one or more clinical sites.

  • May have the following indirect management responsibilities:

o Problem-solving clinical team personnel issues.

o Manages dotted line Study Start Up Specialists and Study Start Up Assistants.

o Providing timely feedback to Study Start Up Team staff on personal and project-specific performance.

o Trains and mentors junior Study Start Up Team members.

  • 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 any relevant and qualifying training

  • Minimum of 4 years of relevant clinical trial experience.

  • Minimum of 1-year clinical trial management or equivalent start-up unit management experience.

o 4-6 years of pharmaceutical or biotechnology industry, preferred.

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

  • Thorough knowledge of Code of Federal Regulations (CFR) and International Council for Harmonization/Good Clinical Practice (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.

  • Ability to coordinate work cross-functionally with diverse teams.

  • Highly responsive and proactive, a team player.

  • Previous start-up unit experience, preferred.

  • Experience managing large teams (direct or dotted line reporting), preferred.

  • Oncology clinical research experience, preferred. • Proficiency with Microsoft Office Products – Word, Excel, PowerPoint, SharePoint.

  • Proficiency in written and spoken English

Job posted: 2023-06-02