Lead Clinical Research Associate - Multiple Positions Job

Organization
Novo Nordisk, Inc.
Job Location
Princeton, NJ
Job Description

PURPOSE:
Responsible for the performance of assigned sites within assigned trials in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations and SOPs. Responsible for operational aspects of planning, managing and execution of site performance in accordance with departmental productivity expectations. Acts as primary liaison between In-House Clinical Research Associates (CRAs), Field-Based CRAs and the Project Manager (PM) for assigned trials. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical Development, Medical and Regulatory Affairs (CMR).

RELATIONSHIPS:
Reports to the Line of Business (LoB) 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 project milestones. 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.

ESSENTIAL FUNCTIONS:

COORDINATION/COMMUNICATION, ADMINISTRATION & PERSONNEL DEVELOPMENT:
* Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals

FUNCTIONAL SUPPORT:
* Participates in continuous improvement processes for function

PROJECT SUPPORT:
* Accountable for providing oversight of the entire site management process for the life cycle of the assigned trial, with the development of essential documents and tracking of site performance metrics
* Accountable for reviewing and approving all trip reports for assigned sites. Accountable for ensuring that any issues are escalated in accordance with the CTM escalation pathway to the PM
* Accountable for the quality of site performance for assigned trial. Responsible to collaborate with the CRA to develop any Corrective Action Plan (CAP)
* Accountable for ensuring that the CAP is delivered and issues escalated to the PM in accordance with the CTM escalation pathway. Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits, including file review according to the CTM Audit Management Plan
* Determines and drives the SSV process (i.e., track and report progress, review data), ensuring that all sites are selected and supplies provided in accordance with study start expectations
* Develops SSV/SIV and other training tools and training materials in support of the project for the project assigned CRAs
* Develops study tools for sites and CRA use
* Ensures that monitoring visits are performed in accordance with protocol/SOP requirements and that these are tracked, including report status and sign off
* Accountable for the quality of the trip report content and sign off timelines for all assigned sites
* Facilitates the review of the trial specific Monitoring Guidelines and ensures that a member of the CRA project team provides input
* Generates potential site list from key stakeholders across CMR and drives site feasibility process in collaboration with the PM
* May develop and finalize the country recruitment/retention strategy in collaboration with the Project Manager (PM)
* Identify potential risks to the enrolment targets based on feasibility analysis in collaboration with the PM
* May provide review of eCRF
* Provides review of protocol and protocol amendments
* Responsible for ensuring internal productivity metrics, especially for trip report completion within the assigned timeframes and to the expectations of CTM
* Responsible for the development and maintenance of the project Q and A documents
* Responsible for the development of any mass site communication as appropriate
* Reviews and ensures all protocol deviations are entered in collaboration with the CRAs
* Reviews and provides input to the Trial Materials Manual and ensure distribution to assigned sites and project team members as appropriate (CRAs)

STAFF DEVELOPMENT:
* May develop and maintain guidelines, training programs, policies and procedures for the functional locally
* May provide active mentorship of CTM staff to build talent across the department
* May support the identification of training gaps within function, may support the development of training materials to meet that gap, and then provide training as required to improve core competency and skill set of the department

TEAM COORDINATION:
* Accountable for the compliance and quality of CATS reporting for self
* Active membership on local project teams. Contributes to Clinical Team Unit (CTU) Meetings
* Participates in cross-functional teams, locally, to assure timely attainment of project milestones
* Responsible for ensuring that the mandatory trial entries are made in IMPACT, novoDOCs, EDC administration and updates, and ensure CSIM entries and updates are made
* Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure
* Responsible to maintain focus, locally, for specific project activities within CMR priorities

TRAINING:
* Attends relevant symposia, conferences and scientific meetings, as necessary

PHYSICAL REQUIREMENTS:
* 30-40% overnight travel required
* Must live within 50 miles of the regional workload center within assigned region

DEVELOPMENT OF PEOPLE:
* Not Applicable

QUALIFICATIONS:
* A Bachelor’s degree required (science-related discipline preferred)
* A minimum of 6 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting is required
* A minimum of 1 year of on-site monitoring experience is required
* A minimum of 4 years of direct expertise of site management and logistical execution of clinical trials is required
* Must have demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
* Must have the ability to demonstrate 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 is required

Department CMR - SITE MANAGEMENT LCRA (2)
Position Location US - Princeton, NJ
City 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.

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