Clinical Operations

  • location: Cambridge, MA
  • type: Contract
  • salary: $70 - $74.21 per hour

job description

Clinical Operations

Job Title: Sr. Manager/Associated Director, Clinical Trial PV Operations III

Position Description

  • Support oversight of Pharmacovigilance activities in Clinical Trials
  • Ensure compliance with global pharmacovigilance requirements
  • Support GCP and PV inspections and audits
  • Through oversight of outsourced activities, ensure all Pharmacovigilance Lead activities are executed consistently throughout all Pre and Post-approval Clinical Studies globally
Position Responsibilities

  • Supporting partner / vendor oversight in relation to Clinical Trial Pharmacovigilance Operations and collaboration with other functions (e.g., Clinical Operations, Global Medical , Data Management, Medical Writing, Regulatory, Biostatistics, and others ) to ensure consistency with regulations and with departmental goals and objectives.
  • Ensuring regulatory compliance with safety regulations globally
  • Ensuring Company fulfils the pharmacovigilance obligations for its global programs
  • Ensuring productive and effective collaboration across functions responsible for clinical trial delivery
  • Liaising with the relevant lead product safety MD as appropriate
  • Ensuring timely support for safety issues & enquiries impacting global programs
  • Supporting strategies for Company compliance with relevant Regulatory Agencies on pharmacovigilance requirements and gaining consensus within Global PV Safety
  • Ensuring effective co-ordination of trial safety logistics globally, drawing input from relevant lead product safety physicians and trials safety managers
  • Monitoring Purchase Orders and ensuring that invoices from vendors are within the scope of the budgeted activities.
  • Contributing to the development and maintenance of pharmacovigilance processes for Company
  • Supporting and maintaining a state of inspection readiness
Position Requirements

  • Bachelor's degree required. Advance degree preferred.
  • Substantial pharmaceutical or health care related industry experience required
  • Must have significant Clinical Trial Operations experience (PV experience is highly preferred) including experience working with CROs, vendors, and relationship management.
  • Demonstrated skills in negotiation and consensus decision making
  • Expert knowledge of clinical trial and pharmacovigilance methodologies preferred.
  • Critical thinking and analytical skills and ability to make and communicatre high level decisions or complex data in cross-functional and global environments.
  • Understanding of and contribution to Company business needs and global strategy
  • Able to interact with personnel from all functional areas and externally to the company at all levels and to represent the department and company in a highly professional manner.
  • Multi-tasking with the ability to successfully manage multiple critical issues simultaneously
  • Demonstrates integrity
  • Project Management abilities
  • Excellent ability to work under high pressure and to manage both time and priority constraints and to manage multiple priorities simultaneously
  • Attention to details, computer literacy, knowledge of EDC
  • Take initiative and autonomous action
  • Able to lead teleconferences and meetings
  • Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills
  • Some travel within Company global sites may be required.

  • 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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