Clinical Study Management

  • location: South Plainfield, NJ
  • type: Contract
  • salary: $52 - $55 per hour

job description

Clinical Study Management

Job Title: Clinical Program Manager

Position Description

  • The Contract Clinical Program Manager provides the scientific and operational expertise required to conduct clinical trials in accordance with appropriate regulatory requirements for one or more indications within or across therapeutic areas. This includes, but is not limited to: working as an integrated member of the clinical team to develop, implement, and manage clinical trial(s) from study design through close out; establishing/managing relationships with assigned investigator sites, vendors and consultants to ensure timelines and deliverables are met and that studies are conducted in accordance with appropriate regulatory requirements. The incumbent also reviews, and contributes to, if needed, the development of clinical study-related documents.
  • The incumbent works cross-functionally with internal departments and external resources on Clinical Research related issues.
  • The Contract Clinical Program Manager supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Position Responsibilities

  • Contributes to the development and or review of clinical study related documents (e.g protocols, protocol amendments, study manuals, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator's Brochures (IBs), Clinical Study Reports (CSRs), regulatory submissions and other documents as required.
  • Establishes and maintains relationships with assigned investigator sites, vendors and consultants.
  • Prepares potential investigator site lists and assists with their evaluation for inclusion in the study; ensures essential clinical documents are in place for assigned sites to ensure timely site initiation and patient enrollment.
  • Ensures investigator and investigator site personnel comply with protocols; recommends corrective action(s) as required.
  • Assists in the oversight of the shipment of, and return of, clinical supplies (drug and non-drug) for assigned sites, as necessary.
  • Performs periodic review of clinical data to ensure the data is accurate and complete.
  • Maintains accurate and updated study files.
  • Assists in the design and implementation of standardized work processes.
  • Participates in the selection and oversight of external service providers, including CROs and other vendors as necessary. Contributes to, and participates in, budget development, contract negotiations and expenditure oversight
  • Prepares investigator site lists for study feasibility and participates in their review and approval for inclusion in the study. Plans, coordinates and participates in investigator meetings including developing and presenting assigned sections of the meeting agenda/content.
  • Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency. Assists in configuration and implementation of study-related systems as appropriate (i.e. data management, study drug tracking, etc.).
  • Performs other tasks and assignments as needed and specified by management.
Position Requirements

  • Bachelor's degree in a scientific discipline and a minimum of 4 years of experience in clinical research working in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment.
  • In-depth understanding of the drug development process.
  • Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
  • Working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
  • Proficiency with Microsoft Office.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Previous experience as a field monitor.
  • Medical writing experience or training.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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