Clinical Trials Project Manager - San Diego, CA | Biospace
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Clinical Trials Project Manager

AnaptysBio, Inc.

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Location:
San Diego, CA
Posted Date:
6/15/2017
Position Type:
Full time
Job Code:
1709
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Project Manager, Project Manager,

Job Description


This position is responsible, within the rapidly expanding AnaptysBio clinical portfolio, for contributing to the management of clinical research programs. Duties  may involve contributions to multiple  clinical studies of differing phases, to include project planning, budgeting, resource management, preparing and negotiating Clinical Trial Agreements, participating in the selection and management of study vendors, organizing and conducting Investigator Meetings and making clinical presentations, etc. The successful candidate will be part of the growing clinical operation team and  will work in close collaboration and liaise with all the developmental functions involved in the progression of the AnaptysBio clinical programs.  Specific responsibilities include:

•   Effectively manage multiple studies and/or programs simultaneously to ensure time, quality, and cost metrics are adequately defined and met. Identify and manage potential risks and impacts with regard to:
       -Site identification/qualification
       -Site start-up and initiation
   -Study conduct
       -Data collection, management, and analysis
       -Final data/reporting
•   Ensure all study activities are in compliance with all applicable regulatory guidelines and GCPs.
•   Negotiate clinical trial agreements and budgets; manage the budget and vendor site payments.
•   Participate in study center selection, pre-study qualification, initiation, and close-out.
•   Conduct co-monitoring or other site visits as warranted.
•   Identify, manage and supervise clinical CRO and consultant activities.
•   Participate in developing study-related documents such as protocols, SOPs, work instruction documents, informed consent forms, case report forms (CRFs), etc.
•   Participate in the preparation and writing of Investigator’s Brochures and clinical sections of regulatory documents such INDs, DSURs, NDAs, etc. (and/or international equivalents).
•   Participate and support publications based on the clinical program.
•   Communicate with cross-functional colleagues (Regulatory, QA, CMC, Finance, etc.) to ensure all stakeholders are informed of and aligned with clinical activities.
•   Recommend and implement innovative process ideas that impact clinical trials management and cost efficiency.

Requirements


•   BA/BS in related scientific or healthcare field and 6+ years of clinical operations experience gained working in a pharmaceutical/biotechnology industry environment, with a strong preference for immunology and antibody/biologics experience; CCRA preferred.
•   Proven ability to plan, conduct and manage clinical operations from pre-clinical through early phase trials, with additional experience in later phases preferable.
•   Demonstrated ability to manage CROs, central laboratories, and other clinical study vendors.
•   Previous experience negotiating vendor/site contracts and fiscal management thereof.
•   Ability to write and edit protocols and other project-related documents, clinical study reports and summary documents for regulatory submissions.
•   Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
•   Demonstrated, effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.
•   International clinical experience is highly preferred.
•   Understanding of country specific, FDA, ICH, and GCP- equivalent requirements, principles, concepts, industry practices, and standards
•   Solid knowledge of drug development and clinical trial operations.
•   Working knowledge of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs.
•   Effective communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams and senior management to build commitment and alignment; listens and seeks clarification; responds effectively to inquiries or complaints.
•   Ability to build strong relationships with external parties, such as key opinion leaders and clinical investigators.
•   Excellent organizational and problem solving skills with the capacity to organize assignments and work within deadlines

Other Information

•   Position may require occasional evening and/or weekend commitment
•   Position may require 25-50% domestic and/or international travel