Clinical Trial Manager
Company: InCarda Therapeutics
Posted on: June 21, 2022
CANDIDATES BASED IN SF BAY AREA PREFERRED
Primary ResponsibilityResponsible for timely execution of clinical
studies such as site feasibility, pre-qualification, site
initiation, routine monitoring and study close out activities.
Ensures compliance with SOPs and Good Clinical Practice. Oversees
and manages CROs, study contractors and vendors. Coordinates the
training of Junior staff involved in clinical trial management.
Responsible for management of timelines and budgets and collection
of study metrics. Coordinates the training of staff involved in
clinical trial management.Key Accountabilities/Core Job
- Assist in the preparation and finalization of project and
study-related documents including: informed consent forms,
pharmacy/lab manual, monitoring plans, synopses, protocols and
amendments, IND annual updates and clinical summaries, as
- Participate in the selection of clinical investigators and
clinical study sites.
- Responsible for responding to clinical study site and study
related issues and recommending corrective actions and/or
escalating to supervisor.
- Coordinate the design, format and content of CRFs, study
guides, study reference binders, patient diaries, and study
logs/forms including participating in the EDC and IVRS
specification process and user acceptance testing.
- Ensure that CRF data queries are resolved appropriately.
- Coordinate and manage Investigational Product including
shipment logistics, overall accountability and reconciliation.
- Coordinates the preparation of clinical site budgets.
- Manage project timelines and vendor performance to meet
departmental and corporate goals.
- Manage payment process (i.e., study site invoices, field
monitor invoices, etc.) for all clinical trial study sites and
field monitors, and/or vendors.
- Monitor and track clinical trial progress and provide status
update reports and study metrics.
- Manage all clinical trial vendors (e.g., IVRS, central labs,
IRB, imaging, central ECG, etc.).
- Responsible for selection of CRO study staff and coordinating
training including documentation.
- Manages the training and oversees study contract field monitors
(e.g., review of all trip reports) and provide guidance on clinical
study site issues.
- Lead with minimal supervision in the planning of investigator
meetings and making presentations, as required.
- Lead with minimal supervision in the review of clinical data at
the CRF, data listing, and report table levels.
- Work independently in a fast-paced environment.
- Attend and/or participate in Site Initiation Visits (SIVs) and
or Investigator Meetings as required.
- Co-Monitoring with field monitor(s) for adherence to protocol
and GCP as required.
- Ensure all trip reports are reviewed and all action items are
followed up per SOPs and work instructions.
- Identify and escalate site, vendor and study related issues to
supervisor, as appropriate.
- Assist with Department compliance initiatives and SOP writing
when opportunity arises.Qualifications
- Ability to exercise independent judgment.
- Good organization and planning skills.
- Strong interpersonal skills and communication skills (both
written and oral).
- Ability to problem-solve and multi task.
- Excellent comprehension of Good Clinical Practices and basic
concepts of clinical research.
- Must be willing to travel at least 25%-35% of the time, as
measured on a calendar quarter. Both domestic andi nternational
travel may be required.Experience
- This position requires a minimum of 6 years of experience in
the pharmaceutical/clinical research environment with at least 2
years of study management experience. People Management is a
Education Requirements (degree, Certifications, Etc.)
- BA/BS/MS in scientific discipline or equivalent combination of
education and related-work experience.Preferred Skills/Abilities
- Experience with development of prospective site-selection
- Protocol development experience.
- Familiar with advanced concepts of clinical research.
- Ability to deal with time demands, incomplete information or
- Experience in interactions with outside vendors, e.g., CROs and
- Experience with administration of site budgets.
- Demonstrated ability to write and present clearly using
scientific and clinical terminology.
Keywords: InCarda Therapeutics, Newark , Clinical Trial Manager, Executive , Newark, California
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