Associate Study Start-Up Manager

This is a fully remote position, open to applicants in United States, +4 more locations.

📋 Description

• Lead and manage the execution of necessary site activation, maintenance, and regulatory tasks for designated studies or multi-protocol programs.

• Supervise Site Activation, which includes pre-award/bid defense activities, and/or Maintenance for assigned projects in alignment with strategy and timelines.

• Develop, execute, and uphold the Management Plan in accordance with the Scope of Work and Project Plan.

• Address project-related challenges as necessary.

• Collaborate across Regulatory & Site Activation, maintaining communication with various regions and countries.

• Create and/or evaluate technical and administrative documents that support business development, study initiation, and maintenance activities.

• Provide expert regulatory and technical scientific assistance for business development, initiation, and maintenance of clinical trials.

• Offer guidance and oversight for multi-regional and multi-protocol programs during the initial start-up and ongoing maintenance phases.

• Define regulatory strategies, expectations, and parameters for submissions and authorizations.

• Recognize regulatory complexities and challenges while developing practical solutions to support the bidding process and site activation plan.

• Evaluate the regulatory landscape and aid in the collection, analysis, interpretation, and dissemination of regulatory intelligence.

• Implement operational strategies for the maintenance of clinical study approvals and authorizations.

• Review and negotiate contracts and essential documentation.

• Collaborate with Quality Management to assure quality standards during site activation or maintenance processes.

• Mentor and coach team members.

• Maintain internal systems, including CTMS, databases, tracking tools, timelines, and project plans.

• Foster long-term relationships with preferred IQVIA clients.

• Present and conduct training sessions for clients, colleagues, and professional organizations.

• Engage in monthly study budget planning and evaluations.

⛳️ Requirements

• A Bachelor's Degree in Life Sciences or a related field is mandatory.

• A minimum of 7 years of relevant experience in a scientific or clinical setting, including significant experience in an international capacity.

• An equivalent combination of education, training, and experience will be considered.

• Strong negotiation and communication abilities with a capacity to challenge effectively.

• Excellent interpersonal skills and a proven team player.

• Demonstrated capability to work through others to achieve results that meet quality and timeline metrics on complex projects.

• Comprehensive understanding of the regulated clinical trial environment and in-depth knowledge of the drug development process.

• Proven proficiency in utilizing systems and technology to fulfill work objectives.

• Strong regulatory and/or technical writing skills.

• In-depth knowledge and ability to apply GCP, ICH guidelines, and relevant regulatory standards.

• Strong leadership capabilities, with the ability to motivate, coach, and mentor others.

• Good organizational and planning abilities.

• Capacity to exercise independent judgment and make calculated risks in decision-making.

• Effective presentation skills.

• Proven ability to establish and maintain productive working relationships with colleagues, managers, and sponsors.

• Excellent understanding of study financial management.

• Proven track record of managing multiple projects while balancing competing priorities.

🏝️ Benefits

• Comprehensive health and welfare benefits.

• Potential incentive plans, bonuses, and/or other compensation forms may be available.