Unternehmen
GCP-Service International Ltd. & Co. KG
Über diese Stelle
28359 Bremen
Medizin, Medizinische Assistenz, Medizinisches Projektmanagement
Festanstellung
Aufgaben
- As a Senior Clinical Data Manager, you will lead and oversee the full lifecycle of clinical data management activities across international studies, ensuring data quality, integrity, regulatory compliance, and cross-functional collaboration.
- You will serve as a key point of contact for internal teams and sponsors, driving strategic data decisions, mentoring junior data managers, aiding in process reviews, contributing to SOP development, and fostering clear communication across the team.
- Our Clinical Data Managers ensure high-quality clinical data management according to GCP-Service or Sponsor SOPs, ICH/GCP guidelines, and national regulations. In this role, you will oversee data management processes from project initiation to completion in an international setting.
- Responsibilities:
- Lead data management activities from study start-up through database lock, ensuring alignment with GCP-Service or Sponsor SOPs, ICH/GCP guidelines, and applicable national regulations.
- Mentor and support junior data managers, contributing to team development and knowledge sharing.
- Oversee the design, testing, and validation of clinical trial databases and electronic data capture (EDC) systems.
- Review and interpret clinical trial protocols to define data collection requirements and ensure protocol compliance.
- Manage data cleaning, discrepancy resolution, and quality control processes to ensure timely and accurate data delivery.
- Collaborate with cross-functional teams (e.g., biostatistics, medical monitoring, pharmacovigilance) to support risk-based decision-making.
- Provide input on data management plans, risk-based monitoring strategies, and process improvements.
- Contribute to the review and refinement of internal processes and workflows.
- Assist in drafting, reviewing, and updating standard operating procedures (SOPs).
- Communicate effectively with sponsors, clients, and internal teams regarding project status, timelines, and critical data issues.
- Mentor and support junior data managers, contributing to team development and knowledge sharing.
- As a Senior Clinical Data Manager, you will lead and oversee the full lifecycle of clinical data management activities across international studies, ensuring data quality, integrity, regulatory compliance, and cross-functional collaboration.
- You will serve as a key point of contact for internal teams and sponsors, driving strategic data decisions, mentoring junior data managers, aiding in process reviews, contributing to SOP development, and fostering clear communication across the team.
- Our Clinical Data Managers ensure high-quality clinical data management according to GCP-Service or Sponsor SOPs, ICH/GCP guidelines, and national regulations. In this role, you will oversee data management processes from project initiation to completion in an international setting.
- Responsibilities:
- Lead data management activities from study start-up through database lock, ensuring alignment with GCP-Service or Sponsor SOPs, ICH/GCP guidelines, and applicable national regulations.
- Mentor and support junior data managers, contributing to team development and knowledge sharing.
- Oversee the design, testing, and validation of clinical trial databases and electronic data capture (EDC) systems.
- Review and interpret clinical trial protocols to define data collection requirements and ensure protocol compliance.
- Manage data cleaning, discrepancy resolution, and quality control processes to ensure timely and accurate data delivery.
- Collaborate with cross-functional teams (e.g., biostatistics, medical monitoring, pharmacovigilance) to support risk-based decision-making.
- Provide input on data management plans, risk-based monitoring strategies, and process improvements.
- Contribute to the review and refinement of internal processes and workflows.
- Assist in drafting, reviewing, and updating standard operating procedures (SOPs).
- Communicate effectively with sponsors, clients, and internal teams regarding project status, timelines, and critical data issues.
- Mentor and support junior data managers, contributing to team development and knowledge sharing.
Fähigkeiten
- Requirements:
- Bachelor’s or Master’s degree in Life Sciences, Biostatistics, Computer Science, or a related field.
- Excellent organizational, and communication skills.
- Proficiency in Microsoft Office.
- Strong understanding of clinical trial processes, regulatory requirements, and data standards.
- Proficiency in Microsoft Office and clinical data systems (e.g., Viedoc).
- Fluent in English and perferably in German (written and spoken).
- Preferred Experience:
- Ability to manage multiple studies and prioritize tasks in a fast-paced environment.
- Familiarity with risk-based study planning.
- Knowledge of eCRF design and validation best practices.
- Requirements:
- Bachelor’s or Master’s degree in Life Sciences, Biostatistics, Computer Science, or a related field.
- Excellent organizational, and communication skills.
- Proficiency in Microsoft Office.
- Strong understanding of clinical trial processes, regulatory requirements, and data standards.
- Proficiency in Microsoft Office and clinical data systems (e.g., Viedoc).
- Fluent in English and perferably in German (written and spoken).
- Preferred Experience:
- Ability to manage multiple studies and prioritize tasks in a fast-paced environment.
- Familiarity with risk-based study planning.
- Knowledge of eCRF design and validation best practices.
Standort
Adresse
28359 Bremen, Deutschland