Manager, Good Clinical Practice Support Job
Purpose
* Responsible for providing support to Clinical Trial Management (CTM) with internal review of clinical trial related documentation, active membership to local CTM SOP Committee, and support to all of the CTM Quality and Audit Management Plans. Provide assistance with training and staff development activities as required by the department, including new hire/on boarding training to support a quality mindset within CTM.
Relationships
* This position reports to the Sr. 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.
Essential Functions
FUNCTIONAL SUPPORT:
* Maintenance of the audit database, CTM Audit Management Plan and may provide support to the clinical project teams with regard to audit action plans.
* Provide quality review of clinical trial documents created within CTM, ICF/protocol/protocol amendments as appropriate.
* Support the implementation of the CTM Quality Management Plan and may provide input into the annual creation of such.
STAFF DEVELOPMENT:
* 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.
* Assess CTM staff members’ understanding of NN process, GCPs and applicable regulations, and assess ability to apply their knowledge in an appropriate manner on site and in adherence to the protocol.
* Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
* Ensure CTM staff understand 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 CTM 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.
* Identify training gaps within CTM. May support the development of training materials to meet that gap, and provide training as required to improve core competency and skill set of the department, especially in relation to the trends identified as part of NNAS GCP audits.
* May assist in identifying individual core learning needs of CTM staff.
* May provide input and maintain guidelines, training programs, policies and procedures for the functional locally.
* May provide input, support and communicate functional, departmental or organizational initiatives.
* Review all Greenlight documentation and provide approval, provide on spot checks of archived clinical trial documentation.
TEAM COORDINATION:
* 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.
* Member of the local CTM SOP Committee.
* Provide and track all activities and assessment schedule for the on- site CRA accompanied visits by CTM Training and GCP Support function.
* 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.
TRAINING:
* 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,
Physical Requirements
* 10-20% overnight travel required
* May require international travel.
Qualification
* A minimum of 3 years prior experience within a quality function within a pharmaceutical company or similar required.
* A minimum of 7 years of progressively responsible, relevant clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required; experience in area of specialty 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 SOPs.
* Demonstrated computer skills (MS Office, MS Excel, MS PowerPoint).
* Previous proven development or line management of industry based clinical trial staff 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. Must have the ability to function independently with minimal supervision.
Department CMR – CTM TRAINING & GCP SUPPORT (2)
Position Location US – Princeton, NJ
City Princeton
State/Provinces US – NJ
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!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
