Work Schedule
Other
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.
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Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
Discover Impactful Work:
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. 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. 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.
A day in the Life:
- Monitors investigator sites with ability to manage complex studies and/or challenging sites using a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- Provides updates on potential trends noted across multiple sites and discusses strategies for their management to the Clinical Team Manager (CTM).
- Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
- Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
- Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
- Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Keys to Success:
Education
Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Experience
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, Abilities
- Expert clinical monitoring skills
- 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
- Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology
- Excellent oral and written communication skills
- Ability to maintain customer focus
- Excellent interpersonal skills
- Excellent organizational and time management skills
- Strong attention to detail
- Ability to remain flexible and adaptable in a wide range of scenarios
- Effective presentation skills
- Ability to utilize problem-solving techniques applicable to constantly evolving environment
- Good digital literacy: proficient knowledge of Microsoft Office
Work Environment
Thermo Fisher Scientific values the health and well-being 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.
- Able to work in non-traditional work environments.
- Able 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 have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
- This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
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!
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.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.