US-NJ, Senior Associate Site Management Documentation Job 447103700A1-MZ
|Requisition ID 52600BR|
Title Senior Associate Site Management Documentation
Job Category Clinical Development
Job Description 1 of multiple positions
Responsible for the support of assigned study activities regarding the implementation, maintenance and closure of a trial in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations and Standard Operating Procedure (SOPs). Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical Medical Regulatory (CMR).
Reports to a Manager/Senior Manager/Associate Director within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned 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: Ensure 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: Accountable for the maintenance of the electronic Trial Master Files (TMF) in accordance with Novo Nordisk (NN) SOPs. Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with NN SOPs, GCP and ICH Guidelines. Accountable to develop and review regulatory documentation to support study activities and answer questions in accordance with the CTM escalation pathway. Arranges for certified translation of study documentation as appropriate. Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of clinical trial documentation. Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NN SOPs. Collaborates with the LCRAs/IHCRAs to obtain/share trial-specific issues across all study sites concentrating on areas related to document management, reconciliation of Monitoring Reports, and Trial Master File reviews. Responsible for communicating issues in accordance with the CTM escalation pathway to the TMs, LCRAs, IHCRAs and/or FCRAs as appropriate. Ensures all regulatory documents are maintained during the lifecycle of any assigned project in collaboration with the study team. Prepares and reviews various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, retrieval of such documents as protocol, IB, etc.). Responsible for the follow up to collect outstanding documents through the study team. Collaborates with LCRA/IHCRA/Study Team to prioritize sites for Greenlight approval. Responsible for the submission and correction of regulatory green light packages to the CTM GCP Support Group for approval. Responsible to coordinate and secure IRB approval (local and central).
Staff Development: May provide active mentorship of CTM staff to build talent across the department. May provide support in the identification of training gaps, 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. May support the maintenance of guidelines, training programs, policies and procedures.
Team Coordination: Active membership to local project teams. Contributes to CORE Team Meetings. Participates in cross-functional teams, locally, to assure timely attainment of project milestones. Responsible for the compliance and quality of CATS reporting for self. Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure. Responsible to ensure that the mandatory trial entries and updates are made in ClinTrack and other systems. Responsible to maintain focus, locally, for specific project activities within CMR priorities.
Training: Attend relevant symposia, conferences and scientific meetings, as necessary. May identify training needs across CTM and provide support of the creation, development and/or training 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 required (in science-related discipline preferred); relevant experience may be substituted for degree, when appropriate and dependent on requirements of the position
* A minimum of 2 years of direct expertise of clinical trial document management and logistical execution of clinical trials within a pharmaceutical, biotechnology, CRO and/or healthcare setting required
* Demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
* Demonstrates core understanding of clinical trial activities in relation to execution of a clinical development plan
* Knowledge of ICH GCP, FDA, IRB/IEC and other applicable regulations/guidelines 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 CTA GROUP (3)
Position Location US - Princeton, NJ
State/Provinces US - NJ
Job/Position Country US
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