Requisition ID 14502BR
Title Associate Manager, Quality Management
Job Category Clinical
Job Description PURPOSE:
Responsible for providing management support to the Clinical Trial Management (CTM) department with internal review of clinical trial related documentation, and management support to all of the CTM Quality and Audit Management Plans. This position is responsible for the development of all CTM quality related trainings and is the liaison between Quality Management and CMR Training to assure that training is developed and executed in accordance with SOPs, ICH, GCP and other related requirements. This position will support the development of training tools/presentations for CTM staff, including new hire/on boarding training to ensure a quality mindset within CTM. Close collaboration with other managers within CTM and with various functional units of NNI.
RELATIONSHIPS:
This position reports to the Associate Director for CTM Quality Management. Multiple internal relationships exist with personnel at all levels of the business, and other functional groups within CTM. External relationships include investigational trial sites and external vendors.
FUNCTIONAL SUPPORT:
- Active membership to local teams as appropriate.
- Active mentorship of CTM staff to build talent across the department.
- Actively follows and manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management of self and instill in all staff across CTM department.
- Assess all individual CTM staff members understanding of NN process, GCPs and applicable regulations and assess their ability to apply their knowledge in an appropriate manner on site and in adherence to the protocol.
- Ensure and manage the consistent implementation of GCPs, SOPs and protocol specific procedures across CTM, through the ongoing assessment of all CTM staff.
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
- Liaison between CTM Quality Management function and CMR Training department to ensure all trainings are developed and executed in accordance with NN global SOPs, ICH, GCP and other requirements as necessary.
- Maintenance of the audit database, CRA Assessment database and provide support to the clinical project teams as needed.
- May provide support and communicate functional, departmental or organizational initiatives.
- Provide quality review of clinical trial documents created within CTM, ICF/protocol/protocol amendments as appropriate
- Review and manage all Greenlight documentation and provide approval, provide on spot checks of archived clinical trial documentation.
- Support the identification of problematic areas and coordinate resolution process with appropriate staff from the output of the onsite visits and collaborates across CTM to resolve them.
- Support the implementation of the CTM Quality Management Plan and will provide input into the annual creation of such.
- Will provide support in the development of guidelines, training programs, policies and procedures for the functional locally.
- Will provide support to identify training gaps within CTM, may support the development of training materials to meet that gap and may provide the training as required to improve core competency and skill set of the department especially in relation to the trends identified. Will provide the logistical support to trainings.
- Will provide support/assistance in identifying individual core learning needs of CTM staff.
TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting as required per departmental expectations.
- Cross team membership, coordination and motivation of the CTM.
- May participate in continuous improvement processes for function.
- May support the implementation of cross departmental work, locally, and communications for assigned as per the clinical development plans.
- May support the implementation of work within cross-functional teams, locally, to assure timely attainment of department milestones within CMR.
- Responsible to ensure that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible to maintain focus, locally, for specific department activities within CMR priorities.
- Responsible to support any activities on behalf of CTM to demonstrate quality mindset.
- Track all activities and assessment schedule for the on site CRA accompanied visits by Quality Management function.
TRAINING:
- Apply adult learning and instructional design principles when developing training programs and materials.
- Attend relevant symposia, conferences and scientific meetings, as necessary
PHYSICAL REQUIREMENTS:
- Approximately 20% overnight travel, potential for international travel
- Office based Princeton NJ position
DEVELOPMENT OF PEOPLE:
- Active mentorship of CTM staff to build talent across the department.
- As a CTM Member responsible for functional support to ensure staff are actively developed in the accordance with the departmental expectations.
- May provide support to maintain guidelines, training programs, policies and procedures for the functional locally.
- May support the identification of training gaps within the department, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree (in science area) or registered nurse, (4 year degree) or equivalent experience demonstrated within a clinical quality support role.
- A minimum of 6 years of clinical trial experience within industry or healthcare setting required.
- Advanced knowledge of Good Clinical Practice (GCPs), ICH Guidelines, federal and local regulations, research process and scientific knowledge as relates to clinical trial conduct through understanding of NN SOPs.
- Demonstrated computer skills (MS Office, EXCEL, PowerPoint).
- Previous 2 years experience within a quality function within a pharmaceutical company or similar required.
- Proven a demonstrated competency in coaching and training of clinical research staff.
- Strong communication (written and verbal), customer focus, analytical, negotiation, meeting and time management, cross-functional team, understanding of a metrics driven organization and strong leadership skills required. Must have the ability to function independently with minimal supervision.
Department CMR - QUALITY MANAGEMENT
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%
Title Associate Manager, Quality Management
Job Category Clinical
Job Description PURPOSE:
Responsible for providing management support to the Clinical Trial Management (CTM) department with internal review of clinical trial related documentation, and management support to all of the CTM Quality and Audit Management Plans. This position is responsible for the development of all CTM quality related trainings and is the liaison between Quality Management and CMR Training to assure that training is developed and executed in accordance with SOPs, ICH, GCP and other related requirements. This position will support the development of training tools/presentations for CTM staff, including new hire/on boarding training to ensure a quality mindset within CTM. Close collaboration with other managers within CTM and with various functional units of NNI.
RELATIONSHIPS:
This position reports to the Associate Director for CTM Quality Management. Multiple internal relationships exist with personnel at all levels of the business, and other functional groups within CTM. External relationships include investigational trial sites and external vendors.
FUNCTIONAL SUPPORT:
- Active membership to local teams as appropriate.
- Active mentorship of CTM staff to build talent across the department.
- Actively follows and manages the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way of Management of self and instill in all staff across CTM department.
- Assess all individual CTM staff members understanding of NN process, GCPs and applicable regulations and assess their ability to apply their knowledge in an appropriate manner on site and in adherence to the protocol.
- Ensure and manage the consistent implementation of GCPs, SOPs and protocol specific procedures across CTM, through the ongoing assessment of all CTM staff.
- Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
- Liaison between CTM Quality Management function and CMR Training department to ensure all trainings are developed and executed in accordance with NN global SOPs, ICH, GCP and other requirements as necessary.
- Maintenance of the audit database, CRA Assessment database and provide support to the clinical project teams as needed.
- May provide support and communicate functional, departmental or organizational initiatives.
- Provide quality review of clinical trial documents created within CTM, ICF/protocol/protocol amendments as appropriate
- Review and manage all Greenlight documentation and provide approval, provide on spot checks of archived clinical trial documentation.
- Support the identification of problematic areas and coordinate resolution process with appropriate staff from the output of the onsite visits and collaborates across CTM to resolve them.
- Support the implementation of the CTM Quality Management Plan and will provide input into the annual creation of such.
- Will provide support in the development of guidelines, training programs, policies and procedures for the functional locally.
- Will provide support to identify training gaps within CTM, may support the development of training materials to meet that gap and may provide the training as required to improve core competency and skill set of the department especially in relation to the trends identified. Will provide the logistical support to trainings.
- Will provide support/assistance in identifying individual core learning needs of CTM staff.
TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting as required per departmental expectations.
- Cross team membership, coordination and motivation of the CTM.
- May participate in continuous improvement processes for function.
- May support the implementation of cross departmental work, locally, and communications for assigned as per the clinical development plans.
- May support the implementation of work within cross-functional teams, locally, to assure timely attainment of department milestones within CMR.
- Responsible to ensure that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible to maintain focus, locally, for specific department activities within CMR priorities.
- Responsible to support any activities on behalf of CTM to demonstrate quality mindset.
- Track all activities and assessment schedule for the on site CRA accompanied visits by Quality Management function.
TRAINING:
- Apply adult learning and instructional design principles when developing training programs and materials.
- Attend relevant symposia, conferences and scientific meetings, as necessary
PHYSICAL REQUIREMENTS:
- Approximately 20% overnight travel, potential for international travel
- Office based Princeton NJ position
DEVELOPMENT OF PEOPLE:
- Active mentorship of CTM staff to build talent across the department.
- As a CTM Member responsible for functional support to ensure staff are actively developed in the accordance with the departmental expectations.
- May provide support to maintain guidelines, training programs, policies and procedures for the functional locally.
- May support the identification of training gaps within the department, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree (in science area) or registered nurse, (4 year degree) or equivalent experience demonstrated within a clinical quality support role.
- A minimum of 6 years of clinical trial experience within industry or healthcare setting required.
- Advanced knowledge of Good Clinical Practice (GCPs), ICH Guidelines, federal and local regulations, research process and scientific knowledge as relates to clinical trial conduct through understanding of NN SOPs.
- Demonstrated computer skills (MS Office, EXCEL, PowerPoint).
- Previous 2 years experience within a quality function within a pharmaceutical company or similar required.
- Proven a demonstrated competency in coaching and training of clinical research staff.
- Strong communication (written and verbal), customer focus, analytical, negotiation, meeting and time management, cross-functional team, understanding of a metrics driven organization and strong leadership skills required. Must have the ability to function independently with minimal supervision.
Department CMR - QUALITY MANAGEMENT
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%