New York, New York
Hawthorne, New York
Ann Arbor, Michigan
Round Rock, Texas
Rock Hill, South Carolina
San Antonio, Texas
Port St Lucie, Florida
Pembroke, North Carolina
Albuquerque, New Mexico
Saint Louis, Missouri
San Antonio, Texas
Location: Irvine, California
Internal Number: US417CKP_BH3564928
• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented, as appropriate.
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements. When issues are identified or trends across a project are noted from MVR review, will escalate deviation issues to CTM/GTL in timely manner.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge enough for role and responsibilities.
• With focus on quality and compliance, will work closely with SM to ensure CAPA is implemented for audits/inspections or any quality related visits. May conduct accompanied site visits with SM, if delegated by FM.
• Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting deliverables and timelines. This includes forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.
• Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals in cooperation with the local Start Up team,
if as applicable.
• May contribute as a trainer of systems/processes or provide input to functional area
in process initiatives, if applicable.
• Full utilization by timely and accurate time reporting.
• Experience in management and startup of complex Early Phase trials projection
Education and Experience Requirements:
• BA/BS degree.
• Degree in a health or science related field.
• 3+ years of local trial management or mutually agreed clinical trial experience.
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.
• Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship now or in the near future.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
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