Study Start Up Specialist

Ergomed • Raleigh, NC

6d • Remote

About The Position

The Study Start Up Specialist coordinates and oversees all activities related to achieving site activations in accordance with the contract, trial protocol, and other study-specific requirements, ICH-GCP, all applicable SOPs, and regulatory requirements. This role takes leadership and acts as the primary point of contact for the Sponsor and internal stakeholders during the study start-up process.

Requirements

• Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
• Minimum 5 years within pharmaceutical/CRO industry
• Proven ability to successfully manage multi-country projects in start-up
• Excellent organizational and management skills
• Strong planning, strategizing, managing, progress monitoring, scheduling, problem-solving and critiquing skills
• Good interpersonal skills in a fast-paced, deadline-oriented, and changing environment
• Excellent self-motivation and motivation skills
• Outstanding knowledge of ICH GCP across all areas

Responsibilities

• Assume leadership during the study Set-up process ensuring development of start-up strategy, effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates.
• Serve as the main point of contact for all project-specific Study Start-Up activities.
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures.
• Prepare, collect, and review regulatory information to support regulatory submissions for initial authorization and maintenance, in compliance with all applicable regulations.
• Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate, or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding the status of essential document collection, review, and approval.
• Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development on site level (if applicable), and Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions/approvals.
• Coordinate with study teams, sponsors, clinical monitoring, clinical contracts, and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation, and site initiation.
• Take ownership in contract negotiations with investigative sites or coordinate other team members assigned to perform contract negotiations as per study-specific RACI.
• Assist with feasibility and site identification activities as needed.
• Arrange for and/or review translation of essential documents as required.
• Attend project team meetings and training sessions according to project and/or Sponsor requirements.
• Ensure all relevant documents are submitted to Trial Master File (TMF) for filing as per study-specific guidance.
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted, and promptly identify and escalate any Out of Scope (OoS) issues.
• Support, mentor, and train department staff and new-hires.
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required.
• Assist with the development and implementation of trainings and SOPs/practice improvements.

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level