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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
Location/Division Specific Information
This role will be embedded within a client dedicated team. You will work alongside the clients own experienced personnel, as well as PPD colleagues to deliver innovative clinical support to non interventional studies
Discover Impactful Work:
As a Junior Project Assistant with a technology-based background, you will support the project management of one or more studies of moderate complexity. Your role will involve assisting with all aspects of project management plan, providing quality oversight to ensure the timely and successful execution of clinical trials.
Key Responsibilities:
* Assist in coordinating the execution of clinical trials from study start-up through database close and inspection readiness.
* Support the development of detailed study start-up and monitoring plans.
* Collaborate with functional lines and CROs to resolve site-level issues.
* Provide input to operational strategy and support decision-making processes.
* Assist in setting realistic recruitment targets and delivery milestones.
* Contribute to the development of Clinical Study Reports and other study documentation.
* Participate in study risk planning and coordinate study/protocol training and investigator meetings.
* Assist in the development and management of Clinical Trial Budgets.
* Support inspection readiness activities related to study management and site readiness.
A Day in the Life:
* Assist in the development of detailed study start-up and monitoring plans.
* Conduct country-level feasibility assessments in collaboration with Global Clinical Trial Execution and CROs.
* Review Pre-trial Assessment outputs and support site activation plans.
* Coordinate study/protocol training and investigator meetings.
* Lead inspection readiness activities related to study management and site readiness.
* Assist in the production or review of model Informed Consent Documents (ICD) and study/country/site level ICDs.
* Expand study design documents into approved protocol templates with input from team members.
Keys to Success:
Education:
* Bachelor's degree in a relevant field.
Experience:
* Demonstrated experience in project planning
* Tech enthusiast with proficiency in spreadsheets, metrics, and data flow management. Planisware. MS Project experience is advantageous
* Fast learner with the ability to quickly adapt to new tools and processes.
Knowledge, Skills, Abilities:
* Strong problem-solving skills and attention to detail.
* Excellent communication skills, both written and verbal. Must be fluent in English.
* Ability to work collaboratively with vendors and team members.
* Understanding of study-level data and ability to identify and mitigate risks.
* Strong interpersonal skills and cultural awareness.
* Ability to interpret and implement study protocols effectively.
Join us and contribute to impactful work by supporting the successful execution of clinical trials and ensuring the delivery of quality study data.
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.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Production, Supply Chain, and Manufacturing
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
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