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23 days old

Senior Clinical Trials Manager

Kelly Services
Waltham, MA 02454
Kelly Science is seeking a **Senior Clinical Trials Manager** for a growing company located in **Waltham, MA.**


**Shift:** **HYBRID** position 8:00am-5:00pm ( Mondays & Fridays are on-site; Tuesday, Wednesday, Thursday are remote)


**Employment Type:** Full Time; Direct Hire


**Summary:**


The Senior Clinical Trials Manager will drive the clinical trial execution activities for assigned clinical trials and ensure trial deliverables are met according to timelines, budget, operational procedures, quality standards, GCP, SOPs and business guidelines.


**Job Duties may include:**


+ Provide input to the clinical development plan and operational aspects of the clinical trial protocol (e.g., develops and/or reviews operational plans for trials).

+ Lead cross-functional trial execution team to ensure delivery of complex clinical trials and manages protocol execution.

+ Identify and/or anticipate operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans to Director/Head of Clinical Operations as necessary.

+ Establish study milestones and ensure accurate tracking and reporting of study metrics, timelines, update of trial information in all trial databases and tracking systems

+ Provide monitoring oversight including authoring of oversight plan, reviewing monitoring visit reports and perform periodic oversight visits to sites and/or vendors to assess progress and compliance.

+ Work closely with the CRO, and internal cross functional groups to drive timelines and study deliverable

+ Manage clinical trial budgets, providing ongoing financial reporting and projections to the finance group and facilitate the development of clinical trial agreements, insurance and other relevant documents in conjunction with legal

+ Ensure the Trial Master File (TMF) is maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial.

+ Serve as functional area reviewer of global clinical / regulatory submissions

+ Present study status reports of operational execution activities to senior management

+ Provide study specific mentor and training for in-house Clinical Research Associate(s) and/or Clinical Trial Assistant(s).

+ Participate in operational process improvement initiatives (including, training, SOP review and development of work instructions/tools/templates).


**Requirements:**


+ 5-8 years of clinical research experience at a biotechnology/pharmaceutical or CRO company

+ Minimum of 5 years of direct clinical study management experience

+ Experience managing early phase drug development studies as well as registrational clinical trials

+ 1-2 years of oncology therapeutic experience preferred

+ Global Clinical Trial Experience and the ability to support more than one clinical trial is required

+ Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required


**Interested? Please apply today for immediate consideration!**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


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 interestsits 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.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-07-20 Expires: 2022-08-20

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Senior Clinical Trials Manager

Kelly Services
Waltham, MA 02454

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