Position Title: Clinical Data Manager

Location: Europe, India
Work Model: Remote/Hybrid
Work Type: Full-Time

Job Summary:

The Clinical Data Manager supports clinical data management activities across all study phases, ensuring data quality, integrity, and compliance with established processes. The Associate Clinical Data Manager provides overall support to the Data Management team. These support activities include, but are not limited to:

• Performing routine data cleaning activities
• Participating in User Acceptance Testing (UAT) activities
• Reviewing Data Management documents

Key Responsibilities:

• Support database development and specification documentation activities.
• Assist with User Acceptance Testing (UAT) and Quality Control (QC) processes.
• Review of Data Management documentation and clinical database data.
• Perform data cleaning, query management, and external data reconciliation.
• Generate and archive patient data reports from the CDMS.
• Support database lock activities and process improvement initiatives.
• Provide day-to-day operational and organizational support to the Data Management team

Qualifications:

• MSc/BSc degree in relevant subjects (statistics, life sciences, pharmacy, economics, management, mathematics, or other related field). 
• 5+  years of experience in similar role. 
• Thorough knowledge of Good Clinical Practices (GCPs) guidelines. 
• Experience handling data within the clinical study process. 
• Strong understanding of the clinical study lifecycle. 
• Excellent problem-solving and data analysis skills. 
• Proficient in Microsoft Excel, SAS Programming, and other statistical software. 
• Strong written and oral communication skills in English. 
• Great attention to detail and a result driven approach. 

Benefits:

• Competitive salary and benefits package tailored to the market.
• Professional development opportunities and access to global industry resources.
• Opportunity to work on innovative clinical trials with leading pharmaceutical and biotech sponsors.

Position Title: Senior Medical Writer

Location: Europe, India
Work Model: Remote/Hybrid
Work Type: Full-Time

Job Summary:

We are looking for an experienced Senior Medical Writer to lead medical writing activities at the project level and ensure the timely delivery of high-quality clinical and regulatory documents.

The role includes preparing, reviewing, and finalizing documents such as study protocols, clinical study reports, Investigator Brochures, regulatory submissions, and publications. The Senior Medical Writer also coordinates document review processes and provides guidance to other Medical Writers, ensuring compliance with applicable SOPs, ICH-GCP, and regulatory requirements.

Key Responsibilities:

• Independently prepare, review, and finalize clinical and regulatory documents for assigned projects.
  • Develop writing strategies, select appropriate templates, and ensure compliance with project-specific and regulatory requirements.
  • Coordinate document development and review processes with cross-functional teams, including clinical, biostatistics, data management, and Sponsors.
  • Lead Medical Writing activities at the project level, including planning timelines, organizing review meetings, and managing document workflows.
  • Ensure high-quality, consistent, and timely delivery of all writing deliverables in line with industry standards and best practices.
  • Provide guidance and support to Medical Writers assigned to the project and contribute to process improvements and writing standards development.
  • Maintain effective communication with project stakeholders, proactively identify risks, and support additional Medical Writing activities as needed.

Qualifications:

• Bachelor’s degree or higher in Life Sciences or Medical Doctor degree. 
• At least 5+ years working experience in regulatory medical writing related to clinical trials. 
• Good knowledge of the overall clinical trial process, thorough knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. 
• Expertise in interpreting and presenting complex clinical data with scientific accuracy and regulatory compliance. 
• Strong leadership, mentoring, and coordination skills (project-level). 
• Proven ability to work independently in a fast-paced environment. 
• Critical thinking and willingness to learn and follow established processes. 
• Multitasking personality with ability to prioritize. 
• Proficiency in Microsoft Office Suit (Office 365, Excel, PowerPoint…etc). 
• Strong written and oral communication skills in English. 
• Great attention to detail and a result driven approach. 
• Excellent problem-solving skills. 
• Assertive personality and strong interpersonal skills. 

Benefits:

• Competitive salary and benefits package tailored to the market.
• Professional development opportunities and access to global industry resources.

Opportunity to work on innovative clinical trials with leading pharmaceutical and biotech.

Position Title: Clinical Research Associate (CRA)
Location: Türkiye
Reports To: Clinical Team Manager
Work Model: Remote/Hybrid
Work Type: Full-Time

Job Summary:
The Clinical Research Associate (CRA) will oversee and monitor clinical trials, ensuring they are conducted in accordance with study protocols, Good Clinical Practice (GCP), and local regulatory requirements. The CRA will establish effective communication with trial sites and verify data accuracy to support high-quality research and patient safety.

Key Responsibilities:

1. Site Management and Monitoring:
   • Conduct site initiation, routine monitoring, and close-out visits as per study requirements.
   • Train site personnel on study protocols and ensure compliance with GCP, regulatory, and ethical guidelines.
   • Confirm that clinical trial sites have adequate supplies, resources, and trained staff to conduct studies.
2. Data Verification and Quality Control:
   • Review source data and case report forms (CRFs) for accuracy, completeness, and adherence to protocol.
   • Identify and resolve discrepancies, maintaining high standards for data quality and integrity.
   • Conduct quality control checks to ensure data aligns with regulatory requirements.
3. Regulatory Compliance:
   • Ensure that all trial activities are conducted in compliance with Serbian regulatory guidelines and international standards.
   • Maintain organized documentation of all monitoring activities.
   • Assist in preparation for regulatory inspections or audits and support follow-up actions.
4. Communication and Reporting:
   • Establish and maintain regular communication with site personnel, clinical project managers, and cross-functional teams.
   • Prepare and submit monitoring visit reports, detailing observations, action items, and recommendations.
   • Address site performance issues and escalate to project managers when necessary.
5. Patient Safety and Adverse Event Reporting:
   • Monitor patient safety throughout the trial process, including review and reporting of adverse events (AEs) and serious adverse events (SAEs) in accordance with protocol and regulatory standards.
6. Continuous Improvement:
   • Stay informed about developments in clinical research practices, regulatory requirements, and industry trends specific to the Serbian market.
   • Participate in training sessions to stay updated on best practices and identify opportunities for process improvements.

Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum 2 years of experience as a CRA, with experience in clinical trials preferred.
• Strong understanding of clinical research regulations, GCP, and industry standards.
• Effective communication and relationship-building skills.
• Detail-oriented with strong organisational and time-management skills.
• Ability to work independently and adapt to local and international team dynamics.

Benefits:

• Competitive salary and benefits package tailored to the market.
• Professional development opportunities and access to global industry resources.
• Opportunity to work on innovative clinical trials with leading pharmaceutical and biotech sponsors.

Position Title: Clinical Research Associate (CRA)
Location: Chile
Reports To: Clinical Team Manager
Work Model: Remote/Hybrid
Work Type: Full-Time

Job Summary:
The Clinical Research Associate (CRA) will oversee and monitor clinical trials, ensuring they are conducted in accordance with study protocols, Good Clinical Practice (GCP), and local regulatory requirements. The CRA will establish effective communication with trial sites and verify data accuracy to support high-quality research and patient safety.

Key Responsibilities:

1. Site Management and Monitoring:
   • Conduct site initiation, routine monitoring, and close-out visits as per study requirements.
   • Train site personnel on study protocols and ensure compliance with GCP, regulatory, and ethical guidelines.
   • Confirm that clinical trial sites have adequate supplies, resources, and trained staff to conduct studies.
2. Data Verification and Quality Control:
   • Review source data and case report forms (CRFs) for accuracy, completeness, and adherence to protocol.
   • Identify and resolve discrepancies, maintaining high standards for data quality and integrity.
   • Conduct quality control checks to ensure data aligns with regulatory requirements.
3. Regulatory Compliance:
   • Ensure that all trial activities are conducted in compliance with Serbian regulatory guidelines and international standards.
   • Maintain organized documentation of all monitoring activities.
   • Assist in preparation for regulatory inspections or audits and support follow-up actions.
4. Communication and Reporting:
   • Establish and maintain regular communication with site personnel, clinical project managers, and cross-functional teams.
   • Prepare and submit monitoring visit reports, detailing observations, action items, and recommendations.
   • Address site performance issues and escalate to project managers when necessary.
5. Patient Safety and Adverse Event Reporting:
   • Monitor patient safety throughout the trial process, including review and reporting of adverse events (AEs) and serious adverse events (SAEs) in accordance with protocol and regulatory standards.
6. Continuous Improvement:
   • Stay informed about developments in clinical research practices, regulatory requirements, and industry trends specific to the Serbian market.
   • Participate in training sessions to stay updated on best practices and identify opportunities for process improvements.

Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum 2 years of experience as a CRA, with experience in clinical trials preferred.
• Strong understanding of clinical research regulations, GCP, and industry standards.
• Effective communication and relationship-building skills.
• Detail-oriented with strong organisational and time-management skills.
• Ability to work independently and adapt to local and international team dynamics.

Benefits:

• Competitive salary and benefits package tailored to the market.
• Professional development opportunities and access to global industry resources.
• Opportunity to work on innovative clinical trials with leading pharmaceutical and biotech sponsors.

Position Title: Clinical Research Associate (CRA)
Location: South Africa
Reports To: Clinical Team Manager
Work Model: Remote/Hybrid
Work Type: Full-Time

Job Summary:
The Clinical Research Associate (CRA) will oversee and monitor clinical trials, ensuring they are conducted in accordance with study protocols, Good Clinical Practice (GCP), and local regulatory requirements. The CRA will establish effective communication with trial sites and verify data accuracy to support high-quality research and patient safety.

Key Responsibilities:

1. Site Management and Monitoring:
   • Conduct site initiation, routine monitoring, and close-out visits as per study requirements.
   • Train site personnel on study protocols and ensure compliance with GCP, regulatory, and ethical guidelines.
   • Confirm that clinical trial sites have adequate supplies, resources, and trained staff to conduct studies.
2. Data Verification and Quality Control:
   • Review source data and case report forms (CRFs) for accuracy, completeness, and adherence to protocol.
   • Identify and resolve discrepancies, maintaining high standards for data quality and integrity.
   • Conduct quality control checks to ensure data aligns with regulatory requirements.
3. Regulatory Compliance:
   • Ensure that all trial activities are conducted in compliance with Serbian regulatory guidelines and international standards.
   • Maintain organized documentation of all monitoring activities.
   • Assist in preparation for regulatory inspections or audits and support follow-up actions.
4. Communication and Reporting:
   • Establish and maintain regular communication with site personnel, clinical project managers, and cross-functional teams.
   • Prepare and submit monitoring visit reports, detailing observations, action items, and recommendations.
   • Address site performance issues and escalate to project managers when necessary.
5. Patient Safety and Adverse Event Reporting:
   • Monitor patient safety throughout the trial process, including review and reporting of adverse events (AEs) and serious adverse events (SAEs) in accordance with protocol and regulatory standards.
6. Continuous Improvement:
   • Stay informed about developments in clinical research practices, regulatory requirements, and industry trends specific to the Serbian market.
   • Participate in training sessions to stay updated on best practices and identify opportunities for process improvements.

Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum 2 years of experience as a CRA, with experience in clinical trials preferred.
• Strong understanding of clinical research regulations, GCP, and industry standards.
• Effective communication and relationship-building skills.
• Detail-oriented with strong organisational and time-management skills.
• Ability to work independently and adapt to local and international team dynamics.

Benefits:

• Competitive salary and benefits package tailored to the market.
• Professional development opportunities and access to global industry resources.
• Opportunity to work on innovative clinical trials with leading pharmaceutical and biotech sponsors.