Associate Manager, Study Start Up - FSP (Sponsor Dedicated)

Job Summary:

The Associate Manager, Study Start Up is 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.

Organizational Relationships:

• Reports to Parexel assigned Line Manager with day-to-day direction from the Client.
• Liaises with cross functional lines as appropriate.

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:
  • Problem-solving clinical team personnel issues.
  • Manages dotted line Study Start Up Specialists and Study Start Up Assistants.
  • Providing timely feedback to Study Start Up Team staff on personal and project-specific performance.
  • 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.

Education and Certification:

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

Skills and Experience:

• Minimum of 4 years of relevant clinical trial experience.
• Minimum of 1-year clinical trial management or equivalent start-up unit management experience.
• 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.

Language Skills:

• Proficiency in written and spoken English
• Proficient in local language (as applicable)