Clinical Study Manager in San Diego, CA at Apex Life Sciences

Date Posted: 5/5/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    San Diego, CA
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    5/5/2018
  • Job ID:
    801710

Job Description


Our Client, a leading pharmaceutical and diagnostic producer, is seeking a Clinical Study Manger to join their team.

Position Summary:

Position responsible for implementation, management and coordination of diagnostic and therapeutic clinical study or studies in one or more Clinical Programs

  • Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and Standard Operating Procedures (SOPs)
  • Assumes leadership role for one or more clinical studies; serving as primary clinical contact for a study including CROs/vendors, Investigators, study coordinators, study nurses, and administrators
  • May develop clinical protocols, informed consent forms, or other study-related clinical documents as applicable (e.g. Case Report Forms, Source Documents, Monitoring Plans, etc.)
  • Facilitate submission of protocol and related documents to Independent Review Boards or Ethics Committees
  • Coordinate activities for identifying/evaluating/selecting the vendors or Contract Clinical Research Organizations (CRO)
  • Determine the delegation of responsibilities to the CRO
  • Contract/Budget negotiation and finalization with CROs, investigators and vendors as needed
  • Development of key clinical operational documents/plans such as monitoring plans and laboratory manuals in conjunction with other team members
  • Identify, qualify, and select clinical sites and investigators to conduct trials
  • Responsible for managing the initiation, monitoring, coordination of study conduct and completion of diagnostic and therapeutic clinical trials
  • Ensure study Trial Master Files (TMFs) are maintained throughout the study period (either electronically or paper copies) and all processes are conducted according to applicable Standard Operating Procedures (SOPs)
  • Review the data management and statistical plans and provide for execution of plan elements
  • Responsible for ensuring data queries are resolved, manage periodic data transfers from CRO or data management vendor as applicable
  • Provide ongoing review of data and final data in tables, listings, figures
  • Contribute to Clinical Study Report development, review, and finalization
  • For all assigned clinical studies, develop and manage a clinical schedule of  tasks, timelines and priorities that aligns with the overall project plan prepared and managed by Project Management
  • Effectively communicate changing priorities, within the team and other relevant parties, as studies progress
  • Develop and maintain effective communication regarding trial conduct within Clinical Operations, Clinical Development, Medical Affairs, R&D, Laboratory Operations, Regulatory, Pharmacovigilance, Marketing, Finance, and Legal departments
  • Assist sites to prepare for audits by Sponsors or regulatory authorities.
  • Assist with internal SOP development
  • Ensure compliance with federal and other regulations, e.g. ISO 13485, GLP, GMP, ICH GCP guidelines(E6) and E2A (Clinical Safety Data & Management, Title 21 CFR parts 11, 50, 54, 56, 99, 312 and 314 and internal guidelines
  • Ensure Serious Adverse Event reporting according to project specification including to the appropriate regulatory authorities where needed
  • Participates in required meetings, activities, and related projects and relevant interdepartmental activities
  • Other duties as assigned.

Requirements:

  • BS/BA degree in a scientific or technical field, advanced degree preferred
  • 7 to 10 years overall clinical research experience with 5 or more years managing clinical trials in a pharmaceutical biotechnology, diagnostic or related industry
  • Proficiency with project management methodologies and techniques
  • Sound understanding of biotech, diagnostic or drug product development activities and of multi-project planning and coordination
  • Demonstrated organizational and leadership skills necessary to integrate several departments toward company objectives
  • Prior direct supervisory experience and matrix management preferred
  • General management knowledge of business processes and concepts
  • Comfortable with finance, budget, and forecasting
  • Knowledgeable of federal and other regulations, e.g. QSRs, ISOs 10006 and 10007, ISO 13485, CMDR, GLP, 21 CFR Parts 50, 54, 56, 99, 312 and 314
  • Proficiency with using Microsoft Project, Outlook, Power Point, Visio project management tools, spreadsheets, and other document management tools

For more information or to apply for this position please contact:

Vickie Dagit, Recuriter

vdagit@apexlifesciences.com

919-334-0178

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.