Clinical Trial Manager (IST)

Location
San Francisco, CA, United States
Posted
Apr 24, 2019
Ref
3697-750-2019
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Responsible for the day-to-day management and operations of ISTs including the management of vendors, clinical monitors and participating IST sites.

Performs a wide variety of activities to ensure studies are executed in accordance with study plans, company procedures, Good Clinical Practice (GCP), ICH guidelines and federal regulations. Identifies risks and contributes to the development of appropriate risk mitigations at the site level. Provides sponsor oversite in alignment with procedural guidance. Exhibits adaptive understanding of the obstacles on their assigned projects. Effectively liaises with external vendors including investigators and Clinical Research Organizations (CROs), and other external partners as applicable. Demonstrates detailed understanding of assigned programs and evaluates the key areas for potential quality concerns in the performance of CROs/vendors and investigative sites. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. Frequently travels to field sites to supervise and coordinate clinical studies. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Provides sponsor oversight of operational activities associated with Investigator Sponsored research including, process and compliance oversite, trial master file documentation, and be a site liason for operational activities. Collaborates in finalizing and approving budgets, plans and detailed timelines; ensures performance expectations are met. Prepares and/or reviews/approves study documents/templates, as appropriate including Pharmacy manuals, safety training and site-related documents (informed consent template and tools/worksheets), investigator contracts, and site payments. Oversight of internal and investigative site activities in accordance with the procedures, Good Clinical Practice (GCP), ICH guidelines and federal regulations. Is in contact with sites to attend to assist with quality oversight, assess performance to plans. Protocol deviation tracking, trending and assessment of preventative action effectiveness, and assessment of risks through key risk indicators. Participates in protocol, and informed consent support as needed by the site, and is the conduit for reivews within Nektar of reports from the site. Will provide operational and project management suport to the Grant Review Committee, managing document flow, feedback and engagement with partners and collaborators where needed. Works with Finance and Drug Supply to ensure resources are in place before commitments are made, and ensures the processes are in place to support compliant execution of of the IST program. May also provide support to other objectives for the Medical Affairs organization.

A Bachelors' degree in a scientific discipline is required. RN or BSN degree is highly desired. Equivalent experience may be accepted. Typically 8 years pharmaceutical development experience with at least 2 years overseeing trial management is required. Strong experience working as a Clinical Research Associate is preferred and thorough knowledge of clinical monitoring practices is required. Must have demonstrated problem solving abilities. Strong organizational skills are required. Strong written and verbal communication skills are required. A thorough understanding of FDA regulatory, ICH, and GCP requirements is required. A thorough understanding of Risk Based Monitoring is desired. Must be able to manage multiple deliverables across multiple studies in a fast-paced team setting. Must have demonstrated good interpersonal skills. Good computer skills are required. Working knowledge of MS Word, Excel, Power point, Outlook is required.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.