Randstad Clinical Operations in Cambridge, Massachusetts

Clinical Operations

job details:

  • location:Cambridge, MA

  • salary:$70 - $74.21 per hour

  • date posted:Wednesday, June 6, 2018

  • job type:Contract

  • reference:25328

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.

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.