Site Specialist, Medical Reviewer- Site Management Job

Requisition ID 13165BR
Title Site Specialist, Medical Reviewer- Site Management
Job Category Clinical
Job Description PURPOSE:
Responsible for performing study activities regarding the management and verification of medical consistency checks (MCC) and/or surveillance of titration of patients within clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Accountable to ensure that clinical investigative site staff adhere to the implementation of the treat-to-target concept to optimize glycemic control without compromising patient safety or data integrity. Responsible for high quality medical data through the medical review of clinical trial data. Close collaboration with other members within Clinical Trial Management (CTM) with focus on program managers and data managers and with various representatives within CMR and with headquarter functional counterparts (international trial management, project data managers, international medical directors and titration committee).

RELATIONSHIPS:
Reports to a Site Management (SM) Manager within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned deliverables and 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 AND 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:
• Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NNI SOPs.
• Attends Investigator Meetings and study-specific training for assigned trials, as appropriate to provide training on MCC and/or titration management.
• Collaborates with the Project Managers (PM) to obtain/share trial specifics issues relating to MCC and /or titration across all study sites concentrating on areas related to quality, site performance and metrics. Responsible for communicating issues in accordance with the CTM escalation pathway PM as appropriate.
• Consults with PM and Medical Director, as appropriate to ensure titration and MCC issues are escalated in a timely manner and in accordance with the CTM Escalation Pathway.
• Develops and maintains collaborative working relationships with clinical investigative sites and study clinicians. Accountable for data integrity, patient safety and regulatory compliance for assigned activities of MCC and titration within assigned studies.
• Ensures local implementation of any treat-to-target concept at the site level and coordination with HQ based titration committee.
• Ensures that all data is captured in the eCRF or CRF in a timely manner. Ensures any queries generated on the data are addressed in a timely manner with the sites and with Data Management (DM).
• Performs MCC of all assigned clinical studies and identifies issues of medical concern and/or inconsistency with the clinical trial data and ensures alignment within project (with CMR study clinicians and International Trial Managers and International Medical Directors).
• Reports status of titration and MCC to internal surveillance staff (PM or Medical Director) as appropriate, following the CTM Communication Plan.
• Responsible for assuring adequate and appropriate dissemination of information according to the study specific communication plan between project team members to ensure project success in accordance with the CTM Communication Pathway or Project Specific Communication Plan.
• Understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.

STAFF DEVELOPMENT:
• May provide active mentorship of CTM staff to build talent across the department.

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

TRAINING:
• Attend relevant symposia, conferences and scientific meetings, as necessary
• Provide support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM.

PHYSICAL REQUIREMENTS:
• Maximum 20% during peak periods (overnight travel to attend trainings/investigator meetings.)
• Office Based Princeton, NJ position

KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
• A Bachelor of Science or a Bachelor of Arts in a scientific discipline with a RN required. Advanced degree preferred.
• Minimum of 3 years of experience in clinical research/clinical trial execution in a pharmaceutical setting.
• Demonstrated computer skills (MS Office, MS Project, PowerPoint).
• Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
• General understanding of the importance of insulin titration and local treatment culture
• Knowledge of GCP as relates to clinical trial management.
Department CMR - SITE MANAGEMENT (3)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 20 - 30%