US-TN, Specialist, Good Clinical Practice Support- Southeast Area Job 437600100A0-MZ
|Requisition ID 50699BR|
Title Specialist, Good Clinical Practice Support- Southeast Area
Job Category Clinical Development
Provide feedback to CRAs and their managers based on findings during on-site visits. Discuss visit outcome trends and findings with CRA Manager/Senior Director of Field Management and/or Senior Director for CTM Training and GCP Support to identify individual and department training needs, and assure a quality mindset across Clinical Trial Management (CTM). Responsible to review, observe, evaluate and report on an ongoing basis on activities related to monitoring by regional Clinical Research Associates (CRAs) associated with the implementation, monitoring, and quality of clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs.
This position reports to the Manager, CTM Training and GCP Support and/or Senior Director for CTM Training and GCP Support. 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.
• 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, and instills in all staff across CTM department. Be primary examples of the Novo Nordisk Way.
• As a CTM member responsible for staff development ensure staff are actively developed in the accordance with the departmental expectations.
• Assess an individual CRAs 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.
• Assist in identifying individual core learning needs of CRAs.
• Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
• Ensure CRA staff understands the principles of assuring patient safety, data integrity and regulatory compliance.
• Ensure the consistent implementation of GCPs, SOPs and protocol specific procedures across CTM, through the ongoing assessment of all CRAs.
• Facilitates discussions and provides constructive and supportive on site coaching to field staff.
• Identify problematic areas and coordinate resolution process with appropriate staff from the output of the onsite visits and collaborates across CTM to resolve them.
• May develop and maintain guidelines, training programs, policies and procedures for the function locally.
• May identify training needs within function or region, and support the development of training materials to meet those needs. May provide training as required to improve core competency and skill set of the department, especially in relation to the trends identified as part of the accompanied CRA visits.
• May provide input, support and communicate functional, departmental or organizational initiatives.
• Provide training and development suggestions for CRAs to the CRA Manager/Senior Director of CTM Training and GCP Support as appropriate.
• Provide verbal and written feedback to CRA and CRA Manager regarding their performance during the visits. Responsible to ensure that any issues identified during the visit relating to site or trial performance are included in the monitoring visit report.
• Randomly schedule and conduct up to 2 accompanied visits per CRA per annum with all CRAs in partnership with the CRA Manager to ensure that each CRA receives a minimum of one accompanied monitoring visit per quarter.
• Submit timely and accurate CRA developmental reports within 10 business days and distribute report to CRA Manager as per procedures.
• Accountable for the compliance and quality of CATS reporting as required per departmental expectations.
• Cross team membership, coordination and motivation of the region across NNI.
• Implements and may participate in continuous improvement processes for function.
• Implements cross departmental work, locally, and communications for assigned as per the clinical development plans.
• Implements work within cross-functional teams, locally, to assure timely attainment of department milestones within CMR.
• Initiates discussions with respective key project stakeholders for clarification and guidance on directives received from others.
• Responsible to ensure that the mandatory trial entries are made in IMPACT, novoDOCs, EDC administration and updates, and ensure Clinical Supplies IVRS Management (CSIM) entries and updates are made.
• Responsible to maintain focus, locally, for specific department activities within CMR priorities.
• Apply adult learning and instructional design principles when developing training programs and materials.
• Attend relevant symposia, conferences and scientific meetings, as necessary.
• Provide support and potential identification of training needs across CTM and direct the creation, development and potentially provide training support to meet those needs, including on-boarding and new hire training.
• 40-50% overnight travel required
• May require international travel.
• Must live within 100 miles of the regional workload center within assigned region.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• A minimum of 1 year of on-site monitoring experience required.
• A minimum of 6 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required.
• A Registered Nurse (RN) or Bachelor’s degree required (in science-related discipline preferred). 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 SOP's.
• Demonstrated computer skills (MS Office, MS Excel, MS PowerPoint).
• Must have the ability to function independently with minimal supervision.
• Previous proven development or line management of CRAs preferred.
• 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.
Department CMR - CTM TRAINING & GCP SUPPORT (1)
Position Location US - Field Based - Across US
State/Provinces US - TN
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
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