Assoc. Director, Clinical Trial PV Operations REMOTE (t330)

  • Contract Duration: 6+ months REMOTE, possibility to extend
  • Clinical
  • Cambridge, MA

Website Lenox Executive Search

Lenox Executive Search is looking to fill a need for an Associate Director, Clinical Trials, PV Operations with one of our global pharmaceutical clients. This is a contract role working REMOTE.

OBJECTIVES of an Associate Director, Clinical Trials, PV Operations:

• 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

ACCOUNTABILITIES of an Associate Director, Clinical Trials, PV Operations:

• 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 the 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 the company’s 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 the organization
• Supporting and maintaining a state of inspection readiness

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS of an Associate Director, Clinical Trials, PV Operations:
• 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 communicate high level decisions or complex data in cross-functional and global environments.
• Understanding of and contribution to The organization 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

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