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Scientific. Clinical. Software Engineering

Clinical Operations Associate Manager

New Jersey All, NJ

Job Type: Clinical Job Number: JN -042020-26685 Region: New Jersey All

Job Description

Responsibilities will include, but are not limited to, the following:

Able to self-direct daily operational management and coordination of assigned Investigator-initiated trials (IITs) from receipt of initial concept to study closure

Track study progress to ensure completion of milestones and deliverables within projected timelines; anticipate potential delays in meeting projected timelines and adjust status accordingly

Interact with team members to ensure consistent performance and quality of work

Operate in accordance with functional guidelines, applicable regulations/guidelines and corporate and local policies/SOPs to ensure compliance, quality, and efficiency

Maintain constant knowledge of assigned studies and provide management with study information as requested

Collaborate with cross-functional stakeholders and liaise with sponsor in the coordination of activities for assigned studies

Contribute to research operations and metrics; identify deficiencies/opportunities and recommend solutions

Develop and promote strong collaborative relationships with internal and external stakeholders demonstrating teamwork

Track study budgets and identify issues related to milestone payments and budget allocations

Hands-on management and tracking of all aspects of IITs/COOPs and maintaining study data within CTMS

Review IIT protocols, regulatory documents, IND safety reports, process study drug supply requests and study payments

Accountable for study activation activities through receipt of study report/ publication

Execute objectives, priorities, and other business critical tasks

Represent US Medical Affairs on assigned cross-functional teams

EDUCATIONAL AND EXPERIENCE REQUIRED:

BS/BA in a health-related science or RN

Minimum of 4 years of Clinical Research experience working on Hematology/Oncology Investigator-Initiated Trials

QUALIFICATION FOR ESSENTIAL FUNCTIONS:

Knowledge of drug development process, FDA, ICH, and GCP guidelines

Excellent communication skills in person, by phone and in writing

Strong sense of time sensitivity

Highly organized with the ability to effectively multi-task on unrelated projects

Ability to work collaboratively, effectively, and productively in diverse organization structures

Works well in a team-oriented, collaborative environment

Ability to demonstrate leadership capabilities

Solid computer skills and advanced knowledge of Databases, MS Word, Excel, PowerPoint

Ability to create and deliver presentations to management or team members

Must be flexible and manage change easily

Ability to work positively within a continually changing environment

Ability to problem-solve

Ability to effectively prioritize and execute tasks in a high-pressure environment


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