US-NJ, Manager Trial Management Job 447103400A1-MZ
|Requisition ID 52590BR|
Title Manager Trial Management
Job Category Clinical Development
Job Description 1 of multiple positions
Responsible for the planning and execution of assigned clinical trials. Close collaboration with other members of Clinical Trial Management (CTM) and with various functional units of Novo Nordisk Inc. (NNI), NN-Canada, and HQ project teams.
Reports to an Associate Director or Director of Trial Management within Clinical Trial Management (CTM). Accountable for actively leading internal cross-functional teams locally to ensure the effective delivery of all clinical trial milestones. External relationships are with clinical investigators, Contract Research Organizations (CROs), and other clinical research vendors as needed to support business objectives.
Leadership of assigned Trial Management Teams (TMTs) which include representatives within CTM as well as from across NACMR as appropriate. Responsible to represent North America with HQ at the International Study Group (ISG) level. Set objectives of the project team according to agreed strategy and approach optimizing speed, quality and cost in compliance with standard process, policies and procedures. Escalates any issues or deviations from agreed plans in a timely manner to CTM Senior Management as well as ITMs. Collaborates with Business Management (BM) function to ensure the US trial budget is developed and managed in line with organizational expectations, including the development of appropriate site-level contracts and budgets.
Accountable for all aspects of vendor management for assigned studies as needed/required. Ensure activities in accordance with contracted terms. Accountable for all project timelines and deliverables. Evaluates and communicates the probability and impact of risks, develops quality and risk management plans for performance and ensures this is integrated into the overall plan for the monitoring management project deliverables in accordance with project plan. Leads the activities relating to the execution of the Audit Management Plan for assigned studies. Accountable for the quality of the execution of clinical trials in partnership with CTM Managers and the assigned Lead Clinical Research Associate (CRA). Accountable for the development of the study specific quality plan. Coordinates mitigation activities to address site quality issues. Participates in Heath Authority (eg, FDA) inspections when necessary. Ensures local protocol amendments are written and submitted in a timely manner in accordance with Standard Operating Procedure (SOPs). Monitors recruitment and retention of trial subjects and takes appropriate actions to mitigate any challenges. Coordinates the review of protocols with relevant CTM, Clinical Medical Regulatory (CMR), and other relevant NNI stakeholders. For local trials, may take responsibility for overall trial planning and set-up including: protocol development and approval, eCRF or CRF development (as appropriate), vendor selection and management, trial-level budget management, coordination with Clinical Supplies, and any other appropriate functions as necessary. Oversees the site selection process in collaboration with the assigned Lead CRA and the BM feasibility team. Accountable that the final study site list is developed according to trial strategy and expectations. Oversees the clinical supply label approval process within the US. Collaborates with NNI meeting planning group and HQ project teams to plan and execute the coordination of Investigator Meetings, as required. Prepares and provides input into materials for Investigator Meetings and Monitors Meetings when required. Presents at Investigator Meetings as required. Responsible to ensure that all data pertaining to study status is compiled and reported timely and accurately to CTM senior management either in presentations or written reports as requested. Engage team members through communication of goals and priorities. May provide active mentorship of CTM staff to build talent across the department. May support the maintenance of guidelines, training programs, policies and procedures. Provide input to line management of project team member’s performance relative to project tasks. Accountable for the compliance and quality of CATS time reporting. Ensures that the mandatory trial entries are made in IMPACT and NovoDOCs, and ensures required updates are made. Ensures the trial files are complete, accurate, and inspection ready. Facilitate appropriate tracking systems for coordination of trial deliverables and enrolment status. Other activities as assigned.
10-20% overnight travel required.
* Bachelor’s degree required (scientific discipline preferred)
* A minimum of 7 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting required. Previous experience leading cross-function clinical trial operations teams preferred
* On-site monitoring experience, or related equivalent experience, preferred
* Analytical, negotiation, meeting management, and team leadership skills required
* Demonstrated computer skills (MS Office, MS PowerPoint). MS Project preferred
* Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
* Experience in international trial management preferred
* Knowledge of GCP as relates to clinical trial management
* Ability to read, write and speak fluent English
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 - GLP DIABETES HOUSE
Position Location US - Princeton, NJ
State/Provinces US - NJ
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
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