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Study Start-up Proj Lead client-based, Ukraine

Employer
Syneos Health
Location
Client-Based, UKR
Salary
Competitive
Start date
15 Jun 2021
Closing date
23 Jun 2021

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong

We are happy to recruit for the position of Study Start-up and Regulatory Specialist I, based in Moscow.

In this role you will be responsible for the following:
  • Providing quality on deliverables at the country level and follow project requirements and applicable country rules.
  • Working within the forecasted submission/approval timelines and ensuring they are complied with
  • Tracking project milestones in the Study Start-up tracking system in real time; providing clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.
  • Monitoring basic financial aspects of the project and the number of hours/tasks available per contract; escalating discrepancies in a timely fashion.
  • Reviewing and complying with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner,
  • Keeping training records updated accordingly and ensuring timesheet compliance.
  • Ensuring all relevant documents are submitted to the Trial Master File (TMF)
  • Working on local submissions together with a Study Start-up Lead
  • Preparing and submitting Central and Local EC Applications, keeping them updated and amending where necessary
  • Supporting the identification and selection of new study sites
Qualifications

You will ideally have the following qualifications:
  • Associate's Degree or equivalent combination of education and training.
  • Good understanding of clinical trial process across Phases II-IV and Good Clinical Practice
  • Ability to interact effectively and appropriately with investigative site personnel.
  • Good organizational skills and good attention to detail
  • Ability to effectively communicate across multiple function groups (clinical team, PM, Director).
  • Quality-driven in all managed activities.
  • Very good English
  • Strong computer skills, including Word, Excel, PowerPoint, Publisher.

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. We look forward to your application.

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