Project Manager (PM) is ultimately responsible for managing the clinical project within the set scope, time and budget and with the highest quality standards as agreed in the contract between the company and the client. 

Main responsibilities include but are not limited to:

  • Project planning (includes preparation of project plans, such as monitoring plan, drug management plan, safety plan, enrolment plan, etc.)
  • Working with Director of Clinical Operations on building the project team 
  • Project team managing, distribution of responsibilities within project team
  • Organization and conduct of Study team meetings
  • Organization and conduct of Study team trainings
  • Organization and conduct of Study Kick-off meeting
  • Management of Investigators meetings 
  • Vendor’s identification and management, including review of vendor’s invoices in terms of performed activities within the scope of work and approval of these invoices prior to their payments 
  • Coordination of study logistics 
  • Creation of study-specific documentation, guidelines, plans
  • Co-monitoring of study sites 
  • Checking reports for all types of visits carried out by CRAs (selection, initiation, routine monitoring, close-out)
  • Reporting to and communication with the Sponsor • Timely reporting on project status to management • Coordination of investigator’s payments • Coordination of hospital payments • Coordination of payments to third-parties • Follow-up on budget issues with the Sponsor  • Coordination of activity of all company’s departments involved in the project 
  • Participation in audits/inspections
  • Participation in OCT trainings, SOP trainings
  • Budgeting various activities related to the study together with the Financial Department and Business Development Department
  • Checking business trip reports prepared by the project team members
  • Conduct other activities as requested by the General Manager

Requirements:

  • Fluent English, written and spoken
  • Minimum 3 year Clinical Research Associate experience or Study Coordinator experience  
  • Minimum 1 year Project managment experience
  • Sound management skills
  • Proven ability to recruit, train and motivate personnel

Conditions:

We are based in Saint Petersburg, Moscow and Kiev and are interested in finding full-time employees Salary is to be determined based on results of the interview

To apply please submit your resume and a cover letter to our Senior Training & Recruitment Manager Victoria Doilnitsyna


This position presumes primarily responsibilities of monitoring (pre-study, initiation, routine, and close-out visits) of investigator sites for the compliance to the study protocol, ICH GCP, company’s SOPs and applicable regulations.The responsibilities will also include negotiations with the investigator sites of clinical trials agreements and study budgets, obtaining and review of required documents from investigator sites.

This position presumes full scope of monitoring responsibilities:

  • Pre-study visits
  • Initiation visits
  • Routine Monitoring visits
  • Close-Out visits
  • Assistance in training of Junior CRAs
  • PM backup when required
  • Assistance in feasibility studies
  • Negotiations of clinical trials agreements with the investigator sites and study budgets
  • Obtaining and review of required study documents from investigator sites.

Conditions:

  • We are based in St. Petersburg with a representative office in Moscow (near the Krasnye Vorota metro station) and are interested in finding full-time employees for both offices
  • Salary is to be determined based on results of the interview

Requirements:

  • Medical Doctor
  • Fluent English, written and spoken
  • Sound management skills
  • Minimum  a year of independent monitoring experience in clinical trials is a must
  • Experience in oncology trials is a plus
  • Ability to travel at least 65% of the working time

Experience in oncology trials will be an advantage!

To apply please submit your resume and a cover letter to our Senior Training & Recruitment Manager Victoria Doilnitsyna

Main responsibilities of Medical Writer include:

  • Developing study design, including determining sample size
  • Consulting customers at the stage of developing study documentation
  • Creating the above mentioned study documents
  • Consulting study team on the study protocol related questions.

Requirements:

  • Degree in medicine or biology; PhD or Dr of Medical Sciences Experience in writing essential documents (including study protocols, subject consent forms, investigator’s brochures, IMPDs, final study reports, CRF, etc) for EMEA or/and FDA clinical trials
  • Knowledge of Russian, European and American legislation on clinical trial design, structure and content of essential documents

Conditions:

  • We are interested in finding full-time. Remote medical writers and freelancers are also welcome!
  • Salary is to be determined based on results of the interview.

To apply please submit your resume and a cover letter to our Senior Training & Recruitment Manager Victoria Doilnitsyna

Clinical Trials Coordinator (CTC) coordinates the work of CRAs and provides assistance to Project Manager in clinical trials conduct.

Responsibilities:

  • To communicate with Sponsor concerning non-medical study issues
  • To assist in organization and holding of study related meetings/trainings
  • To assist in preparation and reporting of project status
  • To control investigators invoices
  • To assist in managing Investigators' Meetings
  • To assist in coordination of activity of all departments and units involved in the project
  • To assist in creation of study specific procedures, preparation of investigator files, maintenance of TMF
  • To translate study documents
  • To assist in regulatory package preparation and submission
  • To assist in preparation of financial reports, others.

Requirements: 

  • Higher education (philology or linguistics preferred)
  • Excellent English and Russian (spoken and written)
  • Ability to work under demanding time schedules
  • Strong leadership and ability to learn
  • Presentation skills 

Conditions:

  • We are based in Saint Petersburg and Moscow and are interested in finding full-time employees
  • Salary is to be determined based on results of the interview

To apply please submit your resume and a cover letter to our Senior Training & Recruitment Manager Victoria Doilnitsyna