Study Start Up Manager - IQVIA Biotech

IQVIA•Durham, NC

2d•$74,600 - $216,000

About The Position

The Study Start Up Manager directs and manages delivery of site activation, maintenance, and regulatory activities for selected studies or multi-protocol programs. This includes pre-award activities and oversight of scope of work, budgets, and resources. The role oversees site activation and/or maintenance in line with the agreed RSU strategy and project timelines, develops and maintains management plans, and resolves project-related issues as needed. The manager provides regulatory, technical, and scientific support for business development, study initiation, and maintenance of clinical trials. As part of the study management team, the role guides multi-regional and multi-protocol programs through start-up and maintenance, determines regulatory strategies and submission requirements, assesses regulatory challenges, and contributes regulatory intelligence. The position also supports quality standards, maintains project information in internal systems, mentors colleagues, and may lead customer relationships, deliver presentations or training, and participate in study budget planning and reviews.

Requirements

Bachelor's degree in life sciences or a related field.
Seven years of relevant experience in a scientific or clinical environment, including demonstrable international experience; an equivalent combination of education, training, and experience is accepted.
Strong negotiation and communication skills, including the ability to challenge.
Excellent interpersonal skills and ability to work as part of a team.
Ability to work through others to deliver complex projects to appropriate quality and timeline measures.
Thorough understanding of the regulated clinical trial environment and in-depth knowledge of the drug development process.
Proficiency in using systems and technology to achieve work objectives.
Good regulatory and/or technical writing skills.
Strong knowledge of, and ability to apply, Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and applicable regulatory guidelines.
Leadership skills, including the ability to motivate, coach, and mentor.
Strong organizational and planning skills.
Ability to exercise independent judgment and take calculated risks when making decisions.
Good presentation skills.
Ability to establish and maintain effective working relationships with co-workers, managers, and sponsors.
Excellent understanding of study financial management.
Ability to manage multiple projects and competing priorities.

Responsibilities

Oversee site activation, including pre-award and bid defense activities, and/or study maintenance for assigned projects in accordance with the RSU strategy and timelines.
Develop, implement, and maintain management plans consistent with the scope of work, project plan, and agreed strategy; resolve project-related issues as needed.
Coordinate across Regulatory and Site Activation, including communication with regions and countries, to deliver project scope in compliance with the RSU Management Plan.
Create or review technical and administrative documentation supporting business development, study initiation, and maintenance.
Provide regulatory, technical, and scientific support for business development and clinical trial initiation and maintenance.
Guide and oversee multi-regional and multi-protocol programs during start-up and maintenance as a member of the study management team.
Determine regulatory strategies, expectations, submission parameters, and required authorizations.
Identify regulatory complexity and challenges and develop practical solutions for the bid process and site activation plan.
Assess the regulatory landscape and contribute to collecting, interpreting, analyzing, and disseminating regulatory intelligence.
Execute operational strategies for maintaining clinical study approvals and authorizations and reviewing or negotiating contracts and essential documents.
Work with Quality Management to maintain appropriate quality standards during site activation or maintenance.
Mentor and coach colleagues as required.
Maintain accurate study information in internal systems, especially CTMS, databases, tracking tools, timelines, and project plans.
May lead the development of long-standing relationships with preferred IQVIA customers.
Deliver presentations or training to clients, colleagues, and professional bodies as required.
May participate in monthly study budget planning and reviews.