Country Clinical Quality Manager

hace 7 meses

Ciudad de México MSD A tiempo completo

**Job Description**:
It is critical that, for all sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The CCQM position has a significant impact in achieving those objectives.

Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM activities in the respective country/cluster.

The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.

Qualifications:

- Bachelor's Degree or equivalent in relevant health care area.

**Experience**:

- A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred.
- Deep knowledge and understanding of Clinical Trial processes, Good Clinical Practices and other clinical research related regulations.
- Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
- Demonstrated experience in leading cross-functional teams.
- Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.
- Ideally, experience in managing audits and inspections.
- Ideally, experience in coordinating and delivering training sessions.

**Skills**:

- Superior oral and written communication and leadership skills in an international environment. Excellent project management and organizational skills.
- Excellent teamwork skills, including conflict resolution expertise and discretion.
- Ability to analyze, interpret, and solve complex problems.
- Ability to think strategically, objectively and with creativity and innovation.
- Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.

Regulations & Processes:

- Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).
- In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).
- Local expert for any quality-related local processes.
- Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary).
- Leads continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM and supports or co-leads continuous improvements activities at the global/regional level.

Training:

- Local training point of contact and the liaison between local country operations and Learning & Development (L&D).
- In close cooperation with local country operations management, identifies / coordinates local training needs.
- Supports local trainings (as needed).

Quality Control (QC) Activities:

- In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes to ensure a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks.
- In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.
- On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required).

Audits & Inspections:

- Primary local point of contact for our Research & Development Division Quality Assurance and Regulatory Agencies.
- Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.
- In cooperation with local country operations and/or headquarters, performs root-cause-analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports.
- On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary) and develops local action plan (incl. sharing of results and training of local country operations, if required).

Quality / Compliance / Privacy Issue Escalation:

- Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.
- Escalat

  • Clinical Project Manager

    hace 7 meses

    Ciudad de México Novartis A tiempo completo

    392018BR **Clinical Project Manager**: Mexico **About the role** **Work Model**:Hybrid **Locality**:Ciudad de Mexico **About the Role**: The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development...

  • Clinical Project Manager

    hace 7 meses

    Ciudad de México Novartis A tiempo completo

    The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements. The CPM is the single point of contact and study team lead,...

  • Clinical Project Manager

    hace 3 semanas

    Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo

    **Job Summary**As a Clinical Trial Manager with Syneos Health, you will be responsible for overseeing site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.**Key Responsibilities**Responsible for site management oversight, clinical monitoring, and...

  • Lead Clinical Research Project Manager

    hace 3 semanas

    Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo

    Job DescriptionWe are seeking an experienced and skilled Clinical Research Project Manager to join our team at Syneos Health. This is a fantastic opportunity for a talented professional to lead clinical research projects from start to finish, ensuring high-quality delivery and compliance with regulatory requirements.Key Responsibilities:Manage clinical...

  • Clinical Operations Manager

    hace 3 meses

    Ciudad de México, CDMX MSD A tiempo completo

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Head COMs, the person is responsible for execution and...

  • Global Clinical Trials Manager

    hace 1 mes

    Ciudad de México, Ciudad de México Eli Lilly and Company A tiempo completo

    Job OverviewWe are seeking a highly skilled Global Clinical Trials Manager to join our team at Eli Lilly and Company.About the RoleThe successful candidate will lead and manage a team of clinical research professionals within the country, collaborating with business partners to ensure clinical trials/studies across all therapeutic areas are executed in...

  • Clinical Trials Leader and Team Manager

    hace 3 semanas

    Ciudad de México, Ciudad de México Eli Lilly and Company A tiempo completo

    OverviewEli Lilly and Company, a global healthcare leader, is seeking a highly skilled Clinical Trials Leader and Team Manager to join our team. This role will be responsible for leading and managing a team of Clinical Research Leads within the country, collaborating with business partners to ensure clinical trials/studies are executed in accordance with...

  • Clinical Data Quality Associate

    hace 2 semanas

    Ciudad de México ICON Plc A tiempo completo

    Clinical Data Quality Associate for Mexico (Office or Home Based) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Clinical Data Quality...

  • Clinical Trials Coordinator

    hace 2 semanas

    Ciudad de México, Ciudad de México Syneos - Clinical And Corporate - Prod A tiempo completo

    About Syneos HealthSyneos Health is a leading biopharmaceutical solutions organization, dedicated to accelerating customer success. We harness unique clinical, medical affairs, and commercial insights to drive outcomes in modern markets.Our Clinical Development model puts the customer and patient at its core, simplifying and streamlining our work to make us...

  • Clinical Associate

    hace 3 semanas

    Ciudad de México ICON Plc A tiempo completo

    Clinical Associate - Mexico City - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The role: As Clinical Associate you would be an...

  • Clinical Operations Director

    hace 1 mes

    Ciudad de México, CDMX MSD A tiempo completo

    This role based in Mexico will be key to further develop the country capabilities in clinical research. Under the oversight of the country CRD the person will be responsible for the end to end performance of clinical trials in one or several TA, from feasibility to close out in one or several countries. The role should be responsible for 30 to 50 clinical...

  • Program Manager, Clinical Data Science

    hace 4 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    Program Manager, Clinical Data Science, Colombia, Home ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We have an incredible opportunity for a...

  • Clinical Data Manager for Clinical Trials

    hace 2 semanas

    Ciudad de México, Ciudad de México Icon Plc A tiempo completo

    We are seeking a highly skilled Clinical Data Manager to join our team at ICON Plc. As a key member of our clinical data management group, you will play a vital role in ensuring the success of our clinical trials.About ICON Plc:Company Overview:ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to shape the...

  • Clinical Quality Associate I

    hace 3 días

    Ciudad de México Curebase A tiempo completo

    **About the role**: Curebase is seeking a Clinical Quality Associate I who will thrive in a quickly scaling healthcare technology environment. Quality at Curebase is deeply cross-functional, and you will work with nearly every function at the company to conduct risk-based quality management (RBQM) surveillance of Clinical Operations activities at Curebase....

  • Clinical Research Associate

    hace 1 mes

    Ciudad de México, CDMX MSD A tiempo completo

    The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary...

  • Specialist, Country Study Start Up

    hace 4 meses

    Ciudad de México, CDMX AbbVie A tiempo completo

    **Company Description** **Job Description**: The Specialist, Country Study Start Up proactively drives and executes all start-up and maintenance-related activities and deliverables for assigned studies and sites in their assigned country or countries. For studies that only involve one country, the Specialist, Country Study Start Up is responsible and...

  • Clinical Associate

    hace 3 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    Clinical Associate - Mexico City - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development - The role: - As Clinical Associate you would be an...

  • Clinical Associate

    hace 3 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    Clinical Associate - Remote - Mexico, Mexico City ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The role: As Clinical Associate you would be...

  • Clinical Trial Manager Ii

    hace 6 días

    Ciudad de México ICON Plc A tiempo completo

    Clinical Trial Manager II - Mexico - Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development At ICON, it’s our people that set us apart. Our...

  • Clinical Associate

    hace 4 meses

    Ciudad de México, CDMX Icon plc A tiempo completo

    Clinical Associate - Mexico - Homebased ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development ICON plc is a world-leading healthcare intelligence and...