Requisition ID 44529BR<br/>Title Manager, Site Management<br/>Job Category Clinical Trial Management<br/>Job Description PURPOSE:<br/>Responsible for the management and development of Site Management staff in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting. Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations. Close collaboration with other managers within Clinical Trial Management (CTM) and with various functional units of Novo Nordisk, Inc. (NNI). Accountable to ensure operating budget and operating margins are managed in accordance with expectations, including expenses.<br/><br/>RELATIONSHIPS:<br/>Reports to the Senior Manager or Associate Director of Site Management within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of all functional and departmental milestones. Reporting to this position are Clinical Trial Associates, In-house Clinical Research Associates (IHCRAs), Site Specialists and/or Lead CRAs. Effectively manages to the direction and strategy for performance within clinical trials at NNI thereby facilitating the CTM department to effectively manage all its business deliverables. External relationships are with clinical investigators, Contract Research Organizations (CROs), and other clinical research vendors as needed to support business objectives for the department and/or function.<br/><br/>ESSENTIAL FUNCTIONS:<br/>BUDGET & CONTRACT COORDINATION:<br/>* Ensures functional operating budget is managed in line with organizational expectations, including expense management<br/>* Ensures that the Site Management (SM) departmental spend is within the % target of agreed annual budget.<br/><br/>COORDINATION/COMMUNICATION, ADMINISTRATION & PERSONNEL DEVELOPMENT:<br/>* Ensures compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals within the assigned staff<br/>* Ensures that all personnel understand and work towards corporate, department and individual goals and that the measures of those goals are understood and accepted<br/>* Ensures that all personnel understand the priorities of the business, are focused on those priorities, and that their level of accountability is understood and accepted<br/>* Responsible for the coaching, development and growth leading directly to improvement of talents of the personnel within the assigned region to meet increasing levels of responsibility<br/><br/>FUNCTIONAL MANAGEMENT & STAFF DEVELOPMENT:<br/>* Accountable for the quality of Site Management staff performance and responsible for the quality of performance across the function<br/>* Active membership to local management teams<br/>* Active mentorship of CTM staff to build talent across the department<br/>* 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<br/>* Cross team membership, coordination and motivation of the function across NNI<br/>* Implements and may participate in continuous improvement processes for function<br/>* May provide input and support the maintenance of guidelines, training programs, policies and procedures for the functional locally<br/>* May support and communicate functional, departmental or organizational initiatives<br/>* May support the identification of training needs within function or assigned personnel, the development of training materials to meet those needs, and provide of training as required to improve core competency and skill set of the department or assigned staff<br/>* Responsible for the implementation and execution of strategies employed by the staff to meet corporate or local goals or directives<br/>* Responsible to ensure proactive management and collaboration on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the Associate Director or head of Site Management as required based on impact at the core business<br/>* Provides guidance and oversight to junior staff on communication of such<br/>* Accountable for all timelines and effective resource deployment. 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 site management CTM business deliverables plan<br/>* Accountable for delivery of the productivity metrics within the assigned timeframes and to the expectations of CTM<br/><br/>FUNCTIONAL OPERATING BUDGET & RESOURCE ALLOCATION:<br/>* Responsible for the assessment and allocation of resources and reviews utilization data on a monthly basis to adjust and manage deployment proactively and effectively<br/>* Responsible for the coordination of site management resource deployment, including integration within project teams, enabling clear understanding and action in relation to the CTM escalation pathway<br/><br/>TEAM COORDINATION:<br/>* Accountable for the compliance and quality of CATS reporting for direct reports<br/>* May support the implementation of cross departmental work, locally, and communications for assigned as per the clinical development plans<br/>* May support the implementation of work within cross-functional teams, locally, to assure timely attainment of department milestones within CMR<br/>* Responsible to ensure that staff are consistently driving and partnering with the project teams to ensure transparency and partnership structure that assures the appropriate updates are provided, that performance is to their expectations and that there clear understanding of expectations as a project team member from the function to ensure to the success of a matrix management structure<br/>* Responsible to ensure that the mandatory trial entries are made in IMPACT, ClinTrack, novoDOCs, EDC administration, and ensure updates are made<br/>* Responsible to maintain focus, locally, for specific department activities within CMR priorities<br/><br/>TRAINING:<br/>* Attend relevant symposia, conferences and scientific meetings, as necessary<br/>* Provide support to needs across CTM and direct the creation, development and potentially provide training support to meet those needs<br/><br/>PHYSICAL REQUIREMENTS:<br/>0-10% overnight travel required<br/><br/>QUALIFICATIONS:<br/>* A Bachelor’s degree is required, preferably in a science related discipline<br/>* A minimum of seven (7) years’ of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting is required<br/>* A minimum of one (1) year of on-site monitoring experience required for management of In-house CRA and Lead CRA roles<br/>* Prior supervisory, project management, or leadership experience is preferred<br/>* Analytical, negotiation, meeting management, cross-functional team and leadership skills are required as demonstrated from representation at a management level<br/>* Must have demonstrated computer skills (MS Office, MS Project, MS PowerPoint, etc.)<br/>* Must have knowledge of GCP as relates to clinical trial management<br/><br/>Department CMR - SITE MANAGEMENT IHCRA (3)<br/>Position Location US - Princeton, NJ<br/>City Princeton<br/>State/Provinces US - NJ
<br/><br/>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
<br/><br/>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!
<br/><br/><p class="eeo_desc">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.<br/><br/>
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.<br/><br/>
If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S. Toll Free number at 1-855-411-5290 or click on the following link to submit your request: <a href="https://www.surveymonkey.com/r/novoaccommodation" target="_blank" title="Accomodation Survey">https://www.surveymonkey.com/r/novoaccommodation</a>. Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.</p>
↧