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 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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Summarized Purpose:
Assists in the management and ongoing evaluation of medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle.
Essential Functions:
- Coordinates and reviews safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites. Identifies potential issues and resolves or escalates as appropriate.
- Reviews safety data and may provide summations for safety review meetings. May review designated sections of aggregate reports.
- May help to create/review safety and medical management plan(s) on studies (as applicable) and ensures that the processes included in plan documents are reflective of the contract and services requested.
- May help manage routine project implementation, forecasting and coordination, including review of metrics and budget considerations.
- Monitors the status of the data review and escalates any delays and/or risks to all stakeholders, including study leads.
- May present at business development, client, and investigator meetings and participate in strategy/business development calls.
- Resolves complex problems through in-depth evaluation of various factors and offers solutions.
- May serve as the primary point of contact for clinical/data management project teams.
- May assist management in training and mentoring.
Education and Experience:
- Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years), to include 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
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:
- Knowledge of GCPs for medical oversight of clinical trials and SAE processing
- Knowledge of drug development and safety reporting
- Knowledge of safety data trending to include coding
- Working knowledge of biostatistics, data management and clinical procedures
- Strong problem solving and critical thinking skills
- Good oral and written communication skills
- Good Strong attention to detail
- Ability to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
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.