Senior Clinical Trial Manager (Remote)
Tandym Group3.8
South San Francisco, CA
Job description
A biotechnology company in California has a great Remote opportunity awaiting a new Senior Clinical Trial Manager. In this role, the Senior Clinical Trial Manager (Remote) will be responsible for managing and leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

Responsibilities:

The Senior Clinical Trial Manager (Remote) will:
  • Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) in order to accurately coordinate clinical study activities
  • Coordinate clinical study timelines with program management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
  • Review monitoring visit reports and perform monitoring oversight visits as needed
  • Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
  • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
  • Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
  • Lead feasibility assessment and selection of countries and sites for study conduct
  • Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
  • Author, audit and/or edit presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals)
  • Lead study coordinator update meetings (either TC or in person) during the study
  • Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
  • Provide oversight and direction to study team members, including vendors, for study deliverables
  • Coordinate with finance to track the financial status against budget

Qualifications:

  • BA/BS degree with 6+ years of direct clinical trial management experience or advanced degree (MS/PhD/PharmD) with at least 7 years clinical trial management experience
  • Must have strong knowledge of ICH/GCP guidelines
  • Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning, management and monitoring
  • Strong experience in management of CROs and other vendors
  • Requires proven Project Management skills and Study Leadership ability
  • Computer savvy
  • Microsoft Office Suite proficient (Word, PowerPoint, Excel and Project)
  • Solid problem solving and time management skills
  • Great interpersonal skills
  • Excellent communication skills (written and verbal)
  • Strong attention to detail
  • Highly organized
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Company details

Headquarters

New York, NY

Employee

201 to 500

Revenue

$5M to $25M (USD)

Industry

Human Resources and Staffing

Company Description
At Tandym Group (formerly The Execu|Search Group), we’re committed to connecting talented people like you with leading companies. With our personalized approach, you’ll never feel like just a resume when you work with us. We know that every job—and every job seeker—is different, which is why we keep the focus on you and your goals. This philosophy has allowed us to help thousands of people find career success over the last three decades, and we’re here to help you do the same. With our extensive network of companies and full suite of direct hire recruitment and contract staffing services, you’ll have access to a variety of roles. We match talent with highly curated opportunities across healthcare, professional services, tech, and life sciences—but it goes far beyond that. When you partner with us, we’re all in. Your goals become our goals, and we are committed to helping you reach your highest potential. From matching you with your dream role to providing resume guidance and interview prep, we’re here for the entire journey. In the constantly changing world of work, you can count on us to be by your side.
Company ratings
  • Overall
    3.8
  • Company & Benefits
    3.5 / 5
  • Culture & Values
    3.6 / 5
  • Career Opportunities
    3.3 / 5
  • Work/Life Balance
    4.0 / 5
  • Senior Management
    3.6 / 5
Company reviews
"The only bad thing is that it was only for awhile"
Former EmployeeNurse
The job was one of those covid jobs. So it ended. But while we were there it was great! The work was satisfying and conditions good. The people both agency nurses and DOH nurses were the best.

"Efficient company with good compensation "
Current EmployeeRegistered Nurse
Everything feels streamlined, from getting hired to training, submitting hours, to getting paid. Everything flows quite well. I’ve worked with a few other agencies, and Execusearch is the best so far.

"Great "
Current EmployeeLicensed Practical Nurse
Very good place to work for! Pay was great, and job communication was very good. Manager easily accessible. Recruiter also was easily accessible. I recommend this job!

"Great company for temp workers "
Former EmployeeRegistered Nurse
It a good place to work if you need a temporary position, my recruiter was great but just lack communication, my assignment was great but again would of love to know more before being toss into assignments