Lead CRA - Oncology Expert - FSP

at  Thermo Fisher Scientific

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.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Considerable clinical research monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) with a demonstrated high level of expertise in all aspects of clinical monitoring.
• Valid driver’s license where applicable.
  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:

• Expert clinical monitoring skills
• Expert oncology knowledge with CAR-T experience
• Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
• Excellent critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Proficient in Risk Based Monitoring concepts and processes
• Skills to mentor and train other monitors in a positive and effective manner
• Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology
• Excellent oral and written communication skills
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Excellent interpersonal skills
• Excellent organizational and time management skills
• Strong attention to detail
• Ability to remain flexibile and adaptable in a wide range of scenarios
• Excellent team player with team building skills
• Effective presentation skills
• Ability to work independently as required
• Ability to utilize problem-solving techniques applicable to constantly changing environment
• Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
• Good English and Finnish language and grammar skills
  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.
  Apply today! http://jobs.thermofisher.co

Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on- site visits to assess protocol and regulatory compliance and manages required documentation.
Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.).
Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness.
Develops collaborative relationships with investigational sites and client company personnel. Assists project manager or clinical team manager on assigned projects and will take a lead role where required.
Supports the line manager to mentor, train and contribute to the development of junior clinical team members.
Detailed tasks and responsibilities assigned to role are outlined in the task matrix
Job Complexity
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Job Knowledge
A seasoned, experienced professional with a full understanding of area of spe
cialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position. S
Business Relationships
Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.