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Scientific Affairs Manager

IBSA Group

This is a Contract position in Parsippany, NJ posted March 24, 2020.

Recruiters need not apply to this posting

As a Scientific Affairs Manager, you will provide clinical research leadership and project oversight. In this position, you will have responsibility for proactively solving issues, and overseeing the successful implementation and monitoring of clinical studies to ensure that studies are conducted in accordance with good clinical practices (GCPs), applicable regulations, standard operating procedures (SOPs) and work instructions.

Responsibilities:

As a Scientific Affairs Manager, you will manage Clinical Research studies including but not limited to:

  • Managing and coordinating the activities of clinical trials including Phase I, II, III, and IV post-marketing and investigator-initiated (IIS) studies.
  • Serving as the main point of contact with investigators and clinical research organizations (CROs) regarding project timelines, updates, needs and emerging issues.
  • Developing study protocols and study training materials for investigator sites.
  • Ensuring project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely IRB approvals for clinical trials.
  • Leading the internal project meetings including Kick-off meetings and Study Initiation meetings.
  • Following screening and recruitment activities to ensure timely enrollment in the studies.
  • Organizing Safety Review Meetings with the principal investigator / sub-investigator / medical and scientific affair team members. Ensure compliance with serious adverse event (SAE) reporting during all sponsored clinical trials.
  • Monitoring project scope and ensuring deliverables are fulfilled within timelines and budget.
  • Ensuring timely interaction with management, sponsors, and/or functional team members on matters concerning resource allocation, project milestones, regulatory issues, and other relevant issues.
  • Organizing investigator site visits (Site qualification visits, Initiation Meetings, Monitoring visits and Close-out visits).
  • Ensure timely completion of clinical study reports.
  • Managing study contracts/budgets, including approval of vendor/site contracts, budgets and invoices. Collaborating with the Finance Department to ensure billing agrees with pre-established milestones.

Requirements:

  • Requires a Bachelor’s degree (Masters a plus) in life sciences or related field.
  • Minimum 3-5 years of experience in clinical research and knowledge of GCP and FDA regulatory requirements is required.
  • Good understanding of the drug development process.
  • Thorough knowledge of GCP and ICH guidelines.
  • Must have previous experience managing projects and in monitoring clinical studies.
  • Excellent written and verbal communication skills, as well as interpersonal skills.
  • Exceptional time management and conflict resolution skills required.
  • Ability to interact with all levels of management, sponsor and study site personnel.
  • Detail-oriented and possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment.
  • CCRC certification preferred.
  • Proficient computer skills in Microsoft Office Suite.
  • Ability to travel up to 40% required