Provides support to the study team and maintains key information in various systems in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations and Novo Nordisk, Inc® (NNI) SOPs.
External relationships are with clinical trial site contacts and/or vendors as needed to support business objectives for the department and/or function. Reports to an Associate Manager / Manager / Senior Manager of Site Management (SM) within Clinical Trial Management (CTM). Accountable for actively participating in internal cross-functional teams locally and globally to ensure the effective delivery of assigned project milestones. This role has close collaboration with other team members within Clinical Trial management.
* Accountable for any mass mailings or communications required to support study execution as directed by study team
* Assists the team in preparation for audits or inspections of Trial Master File (TMF)
* Collects, distributes and tracks receipt of regulatory documents and other trial related documents through the life cycle of the clinical trial as needed
* Compiles key study information from various systems into a report format for tracking and trending metrics for study team
* Creates and maintains logs of trial related documents
* Distributes and tracks CIOMS reports to clinical trial sites and IRBs
* Distributes and tracks protocol deviations
* Distributes, tracks, collates and summarizes feasibility information and provides to study team as needed
* Ensures compliance with the application and communication of all NNI policies, procedures and fundamentals
* Generates potential site information from investigator database
* Maintains trackers for essential trial related documents as needed
* Provides administrative support to study team as needed for trial related tasks
* Responsible for ensuring that the mandatory trial entries are made in novoDOCs, TMF, IMPACT and other relevant systems
* Ensures that clinical trial documents are filed/uploaded accurately and within expected timelines.
* Responsible for properly coding clinical trial documents for archives for the life cycle of the clinical trial, and assures that documents are sent for archiving on a regular basis
* May assist with review of TMF at direction of study team
* Understands assigned protocol(s) and trial specific manuals/plans to ensure quality and that deliverables are met across assigned sites
* Upon notification from study team, updates mandatory dates
* Works on projects as assigned, following company policies, procedures and standards specific to clinical trial management
* May provide active mentorship of CTM staff to build talent across the department
* May provide support in the identification of training gaps, in the development of training materials, and in the provision of training as required to improve core competency and skill sets of the department
* May support the maintenance of guidelines, training programs, policies and procedures
* Accountable for the compliance and quality of CATS reporting
* ?Active membership to local/global project teams
* Participates in cross-functional teams locally/globally to assure timely attainment of project milestones
* Responsible for conducting oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure
* Responsible to maintain focus for specific project activities within CMR priorities
* Attends relevant symposia, conferences and scientific meetings, as necessary
* Approximately 10% overnight travel
* Office based in Princeton, NJ
* Bachelor’s degree required (in science-related discipline preferred); relevant experience may be substituted for degree, when appropriate and dependent on requirements of the position
* ?Ability to handle multiple priorities and demands and work in a fast-paced environment
* Clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare settin
* Experience with Regulatory Documents highly preferred
* Demonstrated computer skills (Microsoft Excel, Word, Outlook, PowerPoint
* Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
* Knowledge of GCP as it relates to clinical trial management
* Strong attention to detail, customer service skills, planning and organizational skills, and written/oral communication skills required
* Working knowledge of electronic trial master files and clinical trial portals preferred
Department CMR - SITE MANAGEMENT CTA
Position Location US - Princeton, NJ
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...cont.