Posted to MedZilla HealthCare on 1/13/2018

Novo Nordisk

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.

Essential Functions
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.

Physical Requirements
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.
Position Location US - Princeton, NJ
City Princeton
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

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.

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: 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.

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