US-NJ, Site Specialist Event Adjudication Job 447103200A1-MZ
|Requisition ID 52586BR|
Title Site Specialist Event Adjudication
Job Category Clinical Development
Responsible for performing study activities regarding the management of the requirements for reporting events for adjudication (EA) within clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and Standard Operating Procedures (SOPs). Accountable to ensure that clinical investigative site staff adhere to the implementation of the requirements for reporting events for adjudication without compromising patient safety or data integrity. Close collaboration with other members within Clinical Trial Management (CTM) with focus on local clinicians, project managers (PM) and with various representatives within Clinical Medical Regulatory (CMR), and with headquarter functional counterparts (international trial management (ITM), international medical directors and Novo Nordisk - Event Adjudication Group).
Reports to a Manager/Senior Manager of Site Management (SM) within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned deliverables and project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.
Coordination/Communication, Administration & Personnel Development: Ensures compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
Functional Support: May participate in continuous improvement processes for function.
Project Support: Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and Novo Nordisk Inc. (NNI) SOPs. Attends Investigator Meetings and study-specific training for assigned trials, and as appropriate to provide training. Collaborates with the PM(s) to obtain/share trial specifics issues relating to EA across all study sites concentrating on areas related to quality, site performance and metrics. Responsible for communicating issues in accordance with the CTM escalation pathway and project teams. Consults with PM and Medical Director, as appropriate to ensure event adjudication issues are escalated in a timely manner and in accordance with the CTM Escalation Pathway. Develops and maintains collaborative working relationships with clinical investigative sites and study clinicians. Accountable for data integrity, patient safety and regulatory compliance for assigned activities of EA within assigned studies. Ensures that all data is captured in the eCRF or CRF in a timely manner. Ensures any queries generated on the data are addressed in a timely manner with the sites, NN-Event Adjudication Group and Safety. Identifies issues of medical concern and/or inconsistency with the clinical trial data and ensures alignment within project (with CMR study clinicians, Event Adjudication Group, International Trial Managers and International Medical Directors). Reports status of EA to PM or Medical Director as appropriate, following the CTM Communication Plan. Responsible for ensuring adequate and appropriate dissemination of information according to the study specific communication plan between project team members to ensure project success in accordance with the CTM Communication Pathway or Project Specific Communication Plan. Understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.
Staff Development: May provide active mentorship of CTM staff to build talent across the department.
Team Coordination: Accountable for the compliance and quality of CATS reporting. Active membership on local project teams, contributor to Clinical Team Unit (CTU) Meetings. Participates in cross-functional teams, locally, to assure timely attainment of project milestones. Responsible for maintaining focus, locally, for specific project activities within CMR priorities. Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
Training: Attends relevant symposia, conferences, and scientific meetings, as necessary. Provides support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM.
10-20% overnight travel required.
* A Bachelor’s degree (in science-related discipline preferred) or Registered Nurse (RN) required
* A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting required; some experience in area of specialty preferred
* Demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
* Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
* Knowledge of GCP as relates to clinical trial management
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Department CMR - SITE MANAGEMENT - SITE SPECIALIST
Position Location US - Princeton, NJ
State/Provinces US - NJ
Job/Position Country US
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