Open opportunities

Currently, we are looking for following (6) possitions:

Clinical Research Associate to be located in Moscow (Russia)

• Coordination and monitoring of the clinical studies (Phase II–IV)
• Communication with Sponsor, Investigators and Vendors
• Medical translation and processing of trial related documentation
• Compliance with Sponsor and Dokumeds SOPs and local regulatory requirements
• Adherence to administrative requirements etc.

• University degree in medicine, pharmacy, nursing or biology
• Previous experience in clinical trials
• Excellent knowledge of Russian, English languages
• Availability to travel
• Strong organizational, communication and teamwork skills
• Computer literacy

Please complete application form in web-page section Career or send your motivation letter and CV in English via e-mail: cv@dokumeds.com

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Clinical Research Project Manager to be located in Moscow (Russia)

• Managing international Phase I-IV clinical trials
• Create and update project plans and timelines to ensure fulfilment of all commitments
• Manage the work within the Project Team and ensure that all internal and external members perform their task during the study process according to agreed timelines and project requirements
• Responsible for timely conclusion of site contracts and ensuring correct processing of payments
• Provide regular status reports to all relevant functions
• Prepare project management reports for clients and internal personnel/management
• Main point of contact for the Sponsor

• University degree in medicine, pharmacy, nursing or biology
• At least 5 years of clinical trial experience in pharmaceutical, device, biotech or CRO setting
• At least 2 years’ experience in manager’s position in pharmaceutical, device, biotech or CRO setting
• Excellent knowledge of Russian, English languages
• Strong leadership (including conflict management), organizational, interpersonal and communication skills, with an ability to prioritize and manage work for a team
• Ability to travel
• Computer literacy

Please complete application form in web-page section Career or send your motivation letter and CV in English via e-mail: cv@dokumeds.com

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Clinical Trial Assistant to be located in Moscow (Russia)

• Assisting in preparation and maintenance of study specific documentation
• Medical translations
• Data tracking and arranging
• Assisting in administrative activities
• Clinical supply (Investigational Product and other materials) handling- distribution to/ from sites, assistance in custom’s clearance process. Maintenance of stock reports and trials supplies flow data
• Site selection and country feasibility activities
• Work on study specific assignments
• Visits to Health Authorities and investigational study sites
• Adherence to administrative requirements
• Communication with clients (Investigators, Sponsors and Vendors)

• Degree in medicine, pharmacy, nursing or related fields
• Excellent knowledge of English, Russian languages
• Strong organisational, communication and teamwork skills
• Knowledge and/ or experience of regulatory affairs will be considered as advantage
• Logistics experience will be considered as advantage
• Accuracy
• Computer literacy

Please complete application form in web-page section Career or send your motivation letter and CV in English via e-mail: cv@dokumeds.com

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Regulatory Affairs Specialist to be located in Moscow (Russia)

• Prepare and submit regulatory documents in accordance with applicable regulations to CEC, RA and LECs
• Coordinate registration process of medical product/ device in accordance with country specific legislation
• Support the preparation and submission of CIOMS, IND Reports and additional information requested by CEC, RA and LEC
• Assure regular communication with CEC and RA on on-going projects and local requirements
• Provide regulatory affairs consultancy and support for projects conducted by Dokumeds in Russia (including registration of medical product/ device)
• Review and follow-up of local legislation updates of regulatory requirements in clinical research and pharmacovigilance field, including registration/ certification conditions of medical product and devices.

• University degree in medicine, pharmacy, nursing or biology
• Previous experience in regulatory affairs and knowledge of local and international regulatory requirements
• Previous experience with marketing authorization
• Excellent knowledge of Russian, English languages
• Strong organizational, communication and teamwork skills
• Computer literacy

Please complete application form in web-page section Career or send your motivation letter and CV in English via e-mail: cv@dokumeds.com

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Clinical Research Associate (CRA) to be located in Warsaw (Poland)

CRA is responsible for study site management including site selection, initiation, routine monitoring, close-out and maintenance of study files. CRA also ensures the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget. 

• Site administration and site monitoring responsibility for clinical studies according to Dokumeds and Sponsor Standard Operating Procedures, legal requirements and ICH-GCP Guidelines
• Conduction of country and site feasibility
• Performance of initiation, routine monitoring and close-out visits
• Preparation and performance of submissions to Ethics Committee/ Regulatory Authorities
• Assistance in project budget and contract management
• Completing Serious Adverse Event (SAE) reporting, processing, production of report

• University degree in medicine, pharmacy, nursing or biology
• Previous experience in independent monitoring
• Excellent knowledge of English, Polish languages
• Thorough knowledge of ICH-GCP guidelines including an understanding of local regulatory requirements
• Availability to travel
• Strong organizational, communication and teamwork skills
• Computer literacy
• Driving license

Please complete application form in web-page section Career or send your motivation letter and CV in English via e-mail: cv@dokumeds.com

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Patient Recruitment Manager

Core responsibility:
Patient recruitment manager is responsible for all patient recruitment activities on strategic level, development and implementation of patient recruitment and retention strategies on corporate level

Key responsibilities:
• Understand fully each protocol assigned, develop, implement and lead the patient recruitment and retention strategy according each protocol requirements
• Maintain and analyse patient recruitment data, identify and assess risks and ensure implementation of required changes to strategy/tactics to achieve contracted recruitment goals
• Provide continuous support and advice to the project team on issues related to patient recruitment
• Develop and maintain patient recruitment database, procedures and documentation on corporate and project levels

• Degree in life sciences or health-care
• Prior experience working in clinical trials and patient recruitment
• Ability to understand and interpret clinical protocols and associated study specifications
• Knowledge and application of GCP, ICH guidelines, local and international regulations.
• Strong presentation, communication (oral and written), documentation, and negotiation skills
• Proficient user of MS Office, particularly Excel
• Excellent English language knowledge (oral and written)
• Strong leadership and organizational abilities and the ability to work in team
• Strategic and analytical thinking
• Previous experience in marketing, advertising will be considered as advantage
• Ability to handle multitasking and work in constantly changing environment

Please complete application form in web-page section Career or send your motivation letter and CV in English via e-mail: cv@dokumeds.com

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