Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
• Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.
• Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.
• Coordinates, under guidance, with internal functional departments to ensure
various site start-up activities are aligned with submissions activities and
mutually agreed upon timelines; ensures alignment of submission process for
sites and study are aligned to the critical path for site activation.
• Achieves PPD’s target cycle times for site.
• May have contact with investigators for submission related activities.
• May act as a key-contact at country level for either Ethical or Regulatory
submission-related activities.
• Works with the start-up CRA(s) to prepare the regulatory compliance review
packages, as applicable.
• Assists in developing country specific Patient Information Sheet/Informed
Consent form documents.
• Assists with grant budgets(s) and payment schedules negotiations with sites.
• Enters and maintains trial status information relating to SIA activities onto PPD,
or client (where contracted) tracking databases in an accurate and timely
manner
• Ensures the local country study files and filing processes are prepared, set up
and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and
current regulatory guidelines as applicable to services provided
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 0 to 2 years).
Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.
Thermo Fisher Scientific Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Thermo Fisher Scientific and has not been reviewed or approved by Thermo Fisher Scientific.
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Retirement Support — The package includes a 401(k) with a strong company match and an employee stock purchase plan, which are viewed as meaningful components of total rewards.
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Leave & Time Off Breadth — Starting paid time off around three weeks, along with paid holidays, sick time, bereavement, volunteer time, and options to add more, is consistently highlighted as a strength.
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Parental & Family Support — Paid parental leave for primary caregivers plus additional bonding time, together with adoption/fertility assistance and childcare benefits, provides robust family support.
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What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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