Trial Project Management Lead
Thermo Fisher Scientific

Job Info

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Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Job Description

Project Manager - FSP Dedicated

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Discover Impactful Work:

We are seeking a Project Manager/Lead or a Sr. CTM in our FSP, Project Management Team.

• This role is for the North America region and is remote based.

The PL Is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Establishes and communicates customer expectations to the project team with minimal direction. Ensures that escalation pathways are adhered to internally and externally. Leads the cross-functional project team to meet or exceed deliverables. Manages project(s) of increasing complexity (such as but not limited to: multi-service, multi-region/country, therapeutic complexity, financial scope). This position must become a trusted partner to and interact early and closely with the accountable Team Members and the associated functional lines to build & maintain high quality project plans in the system.

A day in the Life:

• Serves as the primary contact and lead between the sponsor and the organization at the project level.
• On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).
• Drives and owns the overall delivery of the cross-functional project (time, cost, quality).
• Ensures financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out-of-Scope activity, drive the Con Mod process/negotiations and team execution to timelines.
• Establishes, communicates and manages customer expectations to achieve optimal delivery during the project.
• Drives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE).
• Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.

Keys to Success:

Education

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job
• 5+ years in the pharmaceutical industry and/or clinical research organization.
• 3+ years as clinical study manager (global oversight), with significant study management support experience
• Proven leadership skills
• Previous global experience as study manager and strong vendor management experience.
• Global CTM on a large study, across different regions, with multiple regional CTMs, will be considered.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities

• Comprehensive therapeutic area knowledge, clinical development guidelines and directives and regulatory guidelines .
• Expert knowledge of the key principles of cross functional project management (Time, Quality, Cost).
• Excellent oral and written communication and presentation skills.
• Demonstrated leadership and interpersonal skills including the ability to lead, motivate and coordinate cross-functional project teams.
• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity).
• Proven flexibility and ability to effectively prioritize workload and resources for project team members in a frequently changing environment.
• Skilled in process improvement and strategic development, especially as it applies to clinical trials, clinical development and project management.
• Ability to coach, mentor and lead global and/or cross-functional teams with a cultural awareness.
• Strong financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management.
• Excellent customer service, consultation and relationship building skills.
• Advanced negotiation and marketing skills with ability to influence others and drive results.
• Excellent judgment, decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations.
• Proactive, solutions oriented and skilled at risk identification and management.

• This position must understand the importance of accurate data, how to use it through acquired technical skills, and how to interpret data to draw conclusions (with support from senior colleagues as needed) so that others can make decisions and problem solve.

• Responsible for developing the schedules for activities and deliverables for traditional R&D and Medical Projects (all phases: from pre-CS through Phase IV) to an appropriate level of detail that enables the evolving business needs.

• Expected to recommend changes as opportunities present themselves to improve the efficiency of planning and scheduling of projects to stakeholders.

• Maintains the system data quality by assuring schedule compliance to established business rules, standards and ways of working along with the accountable Project Manager

• Responsible for selecting the appropriate Work Packages within the planning system.

• Build the associated schedules to drive Total Project Cost (TPC) forecast estimates; forecast cost (EPE) and resource (FTE / IPE) associated with integrated plans.

• Partner with key stakeholders including functional Project Managers, etc. to ensure plan schedule alignment to intended strategy.

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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