(Sr) Project Manager, Non-Interventional Clinical Trials Team - Remote in the US

Work Schedule

Environmental Conditions

Job Description

Ideal candidate will be Sr PM level with Global Trial Management experience including a specialty in Non-Interventional Trial Management. Please demonstrate this in your submittal.

(Senior) Project Manager/Lead (Delivery)

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.

Our Project Delivery colleagues within our PPD® clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials. This includes collaborating with functional area leads to identify and evaluate fundamental issues on the project and to ensure that solutions are implemented. Project Delivery is vital to helping our customers deliver life-changing therapies.

Through our global team, you may engage in diverse initiatives and projects, or be part of a virtual international project team gaining cross-cultural experience. Therapeutic scopes include: infectious and respiratory diseases, oncology/hematology, neurosciences, cardiovascular and metabolic, general medicine and vaccines.

Discover Impactful Work:

We are seeking a Project Manager/Lead in our Non Interventional Studies Team. This role will be hired at Project Manager/Senior Project Manager level depending on experience). 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).

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 (comparable to 8+ years).
• 5+ years of management responsibility
• Proven leadership skills

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.

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.