Clinical Trials Management Associate (6058)

Highly Competitive
  1. Permanent
  2. Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Program Manager / Director
  3. United States
Foster City, California
Posting date: 06 Mar 2019
CR.SH.22039_1551873537

ProClinical is partnering with an international biopharmaceutical company to advertise a vacancy for a Clinical Trials Management Associate. This organization boasts a solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs.

The Clinical Trials Management Associate (CTMA) will join this company's office in California, and play a vital role in successfully implementing and supporting important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects.

Job Responsibilities:

  • Serving as the key operational contact with external investigators and internal stakeholders.
  • Evaluating scientific proposals or protocols to identify logistical, regulatory and safety elements, and implications.
  • Managing assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements and financial or product support are processed in a timely manner and to high quality.
  • Proactively identifying operational challenges and collaborating with senior team members to provide and implement solutions to ensure studies remain on track.
  • Forecasting, tracking, and reporting CO and ISR milestones, as well as verifying completeness of the study milestones prior to invoice payment.
  • Providing monthly study updates to the appropriate internal stakeholders.
  • Ensuring all budget or drug supply modifications are appropriately approved, documented, and tracked.
  • Implementing working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
  • Supporting and implementing Clinical Operations Quality Initiatives.
  • Monitoring routine study sites, performing routine data collection, sourcing data verification, and reviewing routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
  • Under supervision, assisting in the development and review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts, and clinical study reports.
  • Assisting in compilation of investigator brochures under close supervision.
  • Assisting in preparation of safety, interim, and final study reports, including resolving data discrepancies.

Skills and Requirements:

  • A BS or BA in a relevant scientific discipline.
  • A minimum of two years relevant clinical experience in the pharmaceutical or health care industry or equivalent.
  • Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials, and ability to understand clinical study protocols a plus
  • Must be proficient with MS Word, PowerPoint, Outlook, and Excel.
  • Must be familiar with routine medical/scientific terminology
  • Must be able to contribute to SOP development.
  • Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Sherron Howard at + 44 267 435 8600 (or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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