Manager, Clinical Research

Organization
N
Job Location
530 Fairview Ave N
Seattle, WA 98109
Salary
DOE/Competitive Comp
Benefits

Stock Options, ESPP, Matching 401K, Annual Bonus, PTO, and more...

Job Description

Job Summary:

NanoString Technologies is seeking an energetic and highly motivated Manager of Clinical Research who will report to the Chief Medical Officer and will be primarily responsible for overseeing the direction, planning, and execution of clinical trials. The Manager, Clinical Research will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements. S/he will monitor adherence to protocols and determine study completion, manage clinical and regulatory files, maintain clinical inventory intended for distribution to investigational sites and interact with investigational sites and Contract Research Organizations.  S/he will have a proven ability to independently prioritize and manage multiple tasks and projects with competing priorities and deadlines. The ideal candidate will be dynamic, articulate, high-energy, organized, and able to support cross-functional coordination in a fast paced environment.

Essential Functions:

  • Coordinate day-to-day activities of clinical trials
  • Manage, train, and mentor a team of less experienced CRAs
  • Adhere to Clinical Operations, Clinical Department[MM1] [MS2] , or project-specific quality documents (e.g., SOPs, work practices, training guides), as applicable
  • Act as Protocol Lead on one or more clinical trials. Protocol Lead responsibilities include:
    • Serve as the main point of contact and coordinate day-to-day activities for all assigned clinical operational and/or clinical trial site monitoring functions
    • Facilitate information flow between all members of the clinical operations/clinical trial site monitoring team, including in-house departments, clinical project team members, external CROs, and other personnel as appropriate
    • If any portion of the clinical trial site monitoring function is conducted by a CRO, ensure performance meets the terms of the contract
  • Participate in the following activities:
    • Design of clinical trial studies in collaboration with senior management, clinical project manager, medical monitor, biostatistician, and regulatory affairs
    • Design and preparation of clinical trial documents such as protocols and case report form
  • As necessary, may also participate in the following:
    • Identification, evaluation, and selection of clinical investigators
  • Develop and lead Quality Control initiatives for a clinical trial
  • Perform the following routine clinical trial site management and monitoring functions:
  • Problem-solve specific clinical trial site issues
  • Monitor clinical trials sites for protocol compliance and GCP/ICH adherence
  • Source document review and comparison to CRF data, CRF review/retrieval and data corrections, maintenance of on-site clinical investigator files, review of IRB/EC documentation, review local laboratory documentation, maintenance and reconciliation of investigational drug supplies, review informed consent process for each subject (Informed Consent Form and source documentation), ensure all Serious Adverse Events (SAEs) have been reported as required, and reconcile with clinical database as required
  • Ensure clinical trial site training records are current and maintained as required
  • Arrange for availability of adequate investigational product supplies, as well as, review of clinical trial site management including storage, accountability, reconciliation and destruction.
  • Conduct clinical trial site monitoring visits and clinical trial site management, including:
    • Adhere to the clinical trial site monitoring plan for each clinical trialConduct pre-study, initiation, monitoring, and close-out visits and telephone contacts
    • Follow-up on all outstanding clinical trial site issues to resolution and/or documenting attempts to resolve all issues following close-out of clinical trial sites
  • Coordinate clinical trial site monitoring staff activities, including review and approval of clinical trial site monitoring reports
  • Compile various data and presenting it to various groups, including clinical sites, project teams, and management
Requirements
  • 8 to 10 years Clinical Monitoring experience in the Biotech Industry, or equivalent
  • Device and/or IVD experience is a plus
  • CCRA certification is a plus
  • Bachelors in scientific discipline or any relevant and qualifying medical training, RN or health care professional - Oncology Clinical Research experience preferred
  • Laboratory experience, including some bench work, is a must
  • Ability to travel (domestic and international)
  • Knowledge of FDA, ICH and local regulations/guidances
  • Previous management experience
  • Proficiency in development of clinical documents
  • Proficiency in Microsoft Office
  • Excellent written communication and organizational skills
  • Ability to understand complex scientific protocols/concepts
  • Excellent clinical trial site monitoring skills
About Our Organization

NanoString Technologies (NASDAQ:“NSTG”) provides life science tools for translational research and molecular diagnostic products. The company's nCounter® Analysis System, which has been employed in basic and translational research since it was first introduced in 2008 and cited in more than 450 peer-reviewed publications, has also now been applied to diagnostic use as the nCounter Dx Analysis System. The company's technology offers a cost-effective way to easily profile the expression of hundreds of genes, miRNAs, or copy number variations, simultaneously with high sensitivity, reproducibility and precision. The company's technology enables a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The nCounter-based Prosigna™ Breast Cancer Prognostic Gene Signature Assay is the first in vitro diagnostic kit to be marketed through the company's diagnostics business. Leveraging the company’s innovative platform and proven development, regulatory and commercial expertise , NanoString has established a companion diagnostics capability to enable biopharmaceuticals partners to translate biomarker discoveries into clinically-relevant diagnostics, helping to bring the right therapy to the right patient at the right time.

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