FSP SrCTM

Job Posted 2 Days Ago Posted 2 Days Ago
Be an Early Applicant
Hiring Remotely in North Carolina
Remote
Senior level
Biotech
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
The Role
As a Senior Clinical Trial Manager (CTM), you will oversee clinical operational and quality aspects of complex studies, manage timelines, regulatory submissions, and clinical resources while ensuring compliance with ICH GCP standards and achieving contractual deliverables.
Summary Generated by Built In

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

The PPD FSP Solution:

PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

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:

As a Sr CTM, you will be accountable for achieving the final clinical deliverable (usually clean data from valuable patients as specified in the study protocol) within the time period specified in the contract with the customer. You will interpret data on sophisticated issues and make good business decisions with support from line management. You will maintain profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.

A day in the Life:

  • Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage sophisticated programs, have wider management or project coordination responsibilities.
  • Develops clinical tools (e.g. Supervising Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as the need arises. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
  • Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and lead steam meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardize clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
  • Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and supervising clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing supervising visit reports, and managing CRF collection and query resolution. Continuously supervises clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
  • Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
  • May coordinate all start-up activities, and ensures that crucial document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.
  • Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
  • In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities.
  • Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.

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).
  • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

  • Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
  • Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
  • Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization
  • Solid understanding of change management principles
  • Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
  • Strong judgment, decision making, escalation, and risk leadership skills
  • Effective oral and written communication skills, including English language proficiency
  • Capable of evaluating own and team members workload against project budget and adjust resources accordingly
  • Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
  • Strong attention to detail
  • In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
  • Strong digital literacy to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
  • Capable of independently managing clinical only studies

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.)

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Top Skills

Excel
Outlook
Word
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Waltham, MA
100,000 Employees
Hybrid Workplace

What We Do

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Why Work With Us

You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.

Gallery

Gallery

Similar Jobs

Remote
United States
1287 Employees
80K-85K Annually

Red Canary Logo Red Canary

Director, Revenue Enablement

Cloud • Security • Software • Cybersecurity
Easy Apply
Remote
USA
420 Employees
153K-200K Annually

Amplify Logo Amplify

2025 Summer Intern

Edtech • Software
Remote
United States
1287 Employees
Remote
United States
1287 Employees
80K-85K Annually

Similar Companies Hiring

SOPHiA GENETICS Thumbnail
Software • Healthtech • Biotech • Big Data • Artificial Intelligence
Boston, MA
450 Employees
Pfizer Thumbnail
Pharmaceutical • Natural Language Processing • Machine Learning • Healthtech • Biotech • Artificial Intelligence
New York, NY
121990 Employees
Takeda Thumbnail
Software • Pharmaceutical • Manufacturing • Healthtech • Biotech • Analytics
Cambridge, MA
50000 Employees
By clicking Apply you agree to share your profile information with the hiring company.

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account