Associate Clinical Trial Manager

Highly Competitive Salary
  1. Permanent
  2. Project/Study Manager (CSM/CPM), Clinical Scientist, Clinical Evaluation
  3. United States
San Mateo, USA
Posting date: 25 Nov 2020

Proclinical is currently recruiting for an Associate Clinical Trial Manager with a pharmaceutical company located in San Mateo, CA.

Job Responsibilities:

  • Serves as the key operational contact with external investigators and internal stakeholders.
  • Has ability to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety implications.
  • Acts as primary contact for study drug planning and shipping with Materials & Logistics.
  • Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
  • Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
  • Provides monthly study updates to the appropriate internal stakeholders.
  • Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
  • Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
  • In collaboration with the Clinical Program Manager (CPM), provides training for new hires, as applicable.
  • Provide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studies.
  • Maintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operations.
  • Organizes and leads review/approval meetings for CO proposal.
  • Actively participates in Clinical Operations Quality Initiatives.
  • Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
  • Performs administrative duties in a timely manner as assigned.
  • With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
  • Assures site compliance with the routine protocol and regulatory requirements and quality of data.
  • May resolve routine monitoring issues.
  • Assists in the setting and updating of study timelines.
  • Assists in CRO or vendor selection.
  • With guidance from supervisor coordinates CROs or vendors.
  • May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports.
  • Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
  • May participate in abstract presentations, oral presentations and manuscript development.
  • Interfaces with individuals in other functional areas to address routine study issues.
  • May be asked to assist in the training of other clinical team members.
  • Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
  • Travel is required.

Skills and Requirements:

  • Bachelor's degree in Science with relevant project management experience, or equivalent/advanced Degree in science with relevant project management experience
  • Minimum 3-5 years pharmaceutical industry experience with knowledge of drug development process.
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
  • Good understanding of financial systems and contracting process (desirable, but not required).
  • Ability to understand clinical study protocols and efficient project management skills
  • Working knowledge of ICH/GCP required. Phase research experience preferred.
  • Working knowledge of MS Word, PowerPoint, Outlook, and Excel.
  • Working 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
  • Ability to collaborate with others to complete assigned tasks.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

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

Proclinical Staffing is an equal opportunity employer.