Start-up Manager, FSP

Thermo Fisher Scientific•Wilmington, NC

About The Position

The Start-up Manager manages complex site operations and supports compliant, timely site activation for clinical studies. The role collaborates across matrixed teams to coordinate site activation, feasibility, contracts, country teams, project resources, and budgets. It monitors project progress, identifies risks, develops contingency plans, and supports communication among PPD teams, clients, and other functions. The manager also contributes to implementation plans, provides project metrics to upper management, helps resolve issues affecting site activation, and develops customer relationships. Occasional domestic and international travel to site locations is required, up to 20% of the time.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Comparable to 5+ years of relevant experience providing the knowledge, skills, and abilities to perform the job.
Ability to work effectively and efficiently with cross-functional teams.
Knowledge of key principles of cross-functional project management.
Organizational and multitasking skills.
Attention to detail.
Ability to identify and remedy risks related to contractual deliverables and provide appropriate solutions.
Understanding of cross-cultural awareness and ability to adapt appropriately.
Comprehensive understanding of clinical research and development, including medical and therapeutic areas, study phases, and medical terminology.
Ability to lead, liaise with, and coordinate cross-functional project teams.
Comprehensive knowledge and understanding of clinical development guidelines and directives.
Ability to access and use a variety of in-house and off-the-shelf computer software.

Responsibilities

Collaborate with matrixed team members to deliver site activation within assigned projects.
May oversee site activation for assigned projects in accordance with timelines and quality standards.
Coordinate the flow of information between PPD teams, clients, and functional departments involved in site activation.
Develop recommended plans and guidelines for project implementation using PPD tools.
Monitor and analyze project status, support successful project progress and completion, and provide metrics to upper management.
Identify project risks and provide contingency planning.
Collaborate with PPD teams on financial and contractual aspects of studies related to site activation.
Establish appropriate controls with the team to align project resources and expenses with budgets, with accountability to Global Project Management.
Administer the technical and operational aspects of site activation, including coordinating feasibility, site contracts, and country teams in a matrix environment.
Manage assigned scope of work against timelines, costs, and quality.
Identify and evaluate issues affecting successful site activation, interpret data on complex issues, make business decisions, and ensure solutions are implemented.
Develop customer relationships in alignment with assigned projects.