Covance Senior Clinical Research Associate/ Quality Management, SCRA, QC, QA in Munich, Germany

Job Description:

Sr CRA for Quality Management, Office based, Munich.

Covance is one of the most stable, fastest growing global Contract Research Organization

Our mission - bringing medical miracles to market sooner - impacts the lives of millions of people all over the world. We play an important role in bringing new therapies to market by helping to turn raw compounds into safe, effective, and approved drugs that help people live longer, more productive lives.

We are one of the world’s most comprehensive and experienced CROs and laboratory services provider, with a tradition of innovation in the science and processes of drug development. We have the ability to offer a wealth of services covering all aspects of drug development, ranging from non-clinical research services through to post-marketing safety and commercialization services. We are currently the only CRO with this depth of service offerings.

We are currently seeking a proactive Senior Clinical Research Associate with a focus on clinical quality management responsibilities to join our expanding CoSource team in Germany (office based in Munich).

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

About the job:

  • GCP and local regulations expert at local level.

  • The Local Lead for Management of Country Standard Operation Procedures (CSOP). In cooperation with country functional area heads: ensures CSOPs are checked/updated regularly; signs/authorizes CSOP deviations along with process owner.

  • Training, process improvement: The Local Quality/Process Improvement and training contact person. In cooperation with country functional area heads and close cooperation with the central teams: identifies local training demand /Initiate local training activities; manages and tracks the training objectives of subsidiary staff.

  • QC, CROs: Defines an annual country QC plan endorsed by Country Clinical Research head. In mutual agreement with the functional area, the SCRA/QM may perform QC activities and field visits. Supports functional area in the qualification process of locally selected vendors and solving of quality issues with locally selected vendors.

  • Audits, inspections, CAPAs: Manages and supports audit preparation activities. In cooperation with country functional area heads: initiates state of the art root cause analysis for Audit and Inspection findings (site and subsidiary Corrective and Preventive Actions and also the tracking until completion); coordinates and facilitates response to Audit and Inspection reports”.

  • Trend analysis, escalation: Undertakes country trend analysis and impact assessments of audit and/or inspection findings and analysis of FA QC activities like Co-Monitoring, to be taken into consideration for country/regional QC plan; initiates actions as needed. Communicate/escalates any trends to country Clinical Research management and QM director as needed.

Vendor Qualification: Leads local vendor qualifications of locally selected GCTO vendors and supports solving of quality issues with locally selected vendors. Supports the Quality Management System (QMS) assessment for global and local vendor qualifications.

About you:

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

o A minimum of several years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. o Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required. o Demonstrated experience leading cross-functional teams of business professionals. o Solid track record of initiating, planning and delivery of projects and knowledge of project management practices. o Ideally, experience in managing audits and inspections. o Ideally, experience in coordinating and delivering training sessions. - Skills: o Superior oral and written communication and people management skills in an international environment. o Excellent project management and organizational skills. o Excellent teamwork and leadership skills, including conflict resolution expertise and discretion. o Ability to analyze, interpret, and solve complex problems. o Ability to think strategically, objectively and with creativity and innovation. o Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.

THERE IS NO BETTER TIME TO JOIN US!

Requisition ID: 63388BR

Job Category: Other

Locations: Germany - Munich

Shift: 1

Job Postings: Sr CRA for Quality Management, Office based, Munich.

Covance is one of the most stable, fastest growing global Contract Research Organization

Our mission - bringing medical miracles to market sooner - impacts the lives of millions of people all over the world. We play an important role in bringing new therapies to market by helping to turn raw compounds into safe, effective, and approved drugs that help people live longer, more productive lives.

We are one of the world’s most comprehensive and experienced CROs and laboratory services provider, with a tradition of innovation in the science and processes of drug development. We have the ability to offer a wealth of services covering all aspects of drug development, ranging from non-clinical research services through to post-marketing safety and commercialization services. We are currently the only CRO with this depth of service offerings.

We are currently seeking a proactive Senior Clinical Research Associate with a focus on clinical quality management responsibilities to join our expanding CoSource team in Germany (office based in Munich).

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

About the job:

  • GCP and local regulations expert at local level.

  • The Local Lead for Management of Country Standard Operation Procedures (CSOP). In cooperation with country functional area heads: ensures CSOPs are checked/updated regularly; signs/authorizes CSOP deviations along with process owner.

  • Training, process improvement: The Local Quality/Process Improvement and training contact person. In cooperation with country functional area heads and close cooperation with the central teams: identifies local training demand /Initiate local training activities; manages and tracks the training objectives of subsidiary staff.

  • QC, CROs: Defines an annual country QC plan endorsed by Country Clinical Research head. In mutual agreement with the functional area, the SCRA/QM may perform QC activities and field visits. Supports functional area in the qualification process of locally selected vendors and solving of quality issues with locally selected vendors.

  • Audits, inspections, CAPAs: Manages and supports audit preparation activities. In cooperation with country functional area heads: initiates state of the art root cause analysis for Audit and Inspection findings (site and subsidiary Corrective and Preventive Actions and also the tracking until completion); coordinates and facilitates response to Audit and Inspection reports”.

  • Trend analysis, escalation: Undertakes country trend analysis and impact assessments of audit and/or inspection findings and analysis of FA QC activities like Co-Monitoring, to be taken into consideration for country/regional QC plan; initiates actions as needed. Communicate/escalates any trends to country Clinical Research management and QM director as needed.

Vendor Qualification: Leads local vendor qualifications of locally selected GCTO vendors and supports solving of quality issues with locally selected vendors. Supports the Quality Management System (QMS) assessment for global and local vendor qualifications.

About you:

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

o A minimum of several years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. o Deep knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required. o Demonstrated experience leading cross-functional teams of business professionals. o Solid track record of initiating, planning and delivery of projects and knowledge of project management practices. o Ideally, experience in managing audits and inspections. o Ideally, experience in coordinating and delivering training sessions. - Skills: o Superior oral and written communication and people management skills in an international environment. o Excellent project management and organizational skills. o Excellent teamwork and leadership skills, including conflict resolution expertise and discretion. o Ability to analyze, interpret, and solve complex problems. o Ability to think strategically, objectively and with creativity and innovation. o Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.

THERE IS NO BETTER TIME TO JOIN US!

Education/Qualifications: .

Experience: .

EEO Statement:

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.