Clinical Study Manager, FSP - IVD Experience Required

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

REMOTE:

We welcome applicants from all locations within the US.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

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.

We have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Summarized Purpose: 
Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer.  Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. 

Essential  Functions

• 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 complex programs, have wider management or project coordination responsibilities.
• Develops clinical tools (e.g. Monitoring 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 required.
• 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 leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized 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 monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors 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 essential 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.
   

Job Complexity:  Works on complex issues where analysis of situations or data requires an in-depth  evaluation of variable factors.
Job Knowledge: Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau.
Supervision Received
Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
Business  Relationships: Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise.

Qualifications: 
Education and Experience: 
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

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 and Abilities: 

• Strong leadership skills, effective at mentoring and training, and capable of motivating and  integrating teams
• Strong In Vitro Diagnostic Devices Regulations (IVDR), and ISO20916
• 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 management 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 computer skills to effectively use automated systems and computerized applications such as  Outlook, Excel, Word, etc.
• Capable of independently managing clinical only studies

Management Role:
No management responsibility

Working Conditions and Environment: 
· Work is performed in an office environment with exposure to electrical office equipment. 
· Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:
· Frequently stationary for 6-8 hours per day. 
· Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements  of the fingers, hands, and wrists. 
· Frequent mobility required. 
· Occasional crouching, stooping, bending and twisting of upper body and neck. 
· Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop  computer with a maximum lift of 15-20 lbs. 
· Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
· Ability to communicate information and ideas so others will understand; with the ability to listen to  and understand information and ideas presented through spoken words and sentences. 
· Frequently interacts with others to obtain or relate information to diverse groups. 
· Works independently with little guidance or reliance on oral or written instructions and plans work  schedules to meet goals. Requires multiple periods of intense concentration. 
· Performs a wide range of variable tasks as dictated by variable demands and changing conditions  with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. 
· Regular and consistent attendance.

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!