Use our `search` to find similar offers.
Associate Manager, Study Start Up (FSP)
Parexel International Corporation
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.
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.
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