"Lighting a Path to the Future"

Clinical Trials Manager

Location: Waltham, MA
Job Type: Direct Hire
Salary: $105,000.00 - $120,000.00
Date: 3/5/2018
Job ID: 02166055
Job Description
Incredibly successful publicly traded Biotech in Waltham , Massachusetts is expanding due to their clinical trial success.
Looking for a Strong Clinical Trials Manager or Senior Clinical Trials Manager to help lead their Phase 2 and 3 trials in anti-cancer partner drugs.

This company has three wholly owned therapies- in late stages, with a fourth starting in phase I.

This CTM is focused on the anti- cancer phase III trials.
If you are an experienced Clinical Trials Manager
with oncology experience, please consider sending us your resume for review 


The Opportunity
The Clinical Trial Manager/Senior Clinical Trial Manager works closely with internal team members and vendors to ensure that assigned clinical trials are conducted per protocol, in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and established study budgets.

Job Responsibilities

  • Ensuring the execution of assigned clinical trials in accordance with study protocol, GCP/ICH, regulatory requirements and Clinical Standard Operating Procedures.
  • Planning and running Site Initiation Visits.
  • Coordinating and providing oversight to the site contracting and budgeting process.
  • Developing and manage the timelines for assigned clinical trials to support the goals of the Clinical Development Plan and to ensure they continue in-line with the strategic imperatives of the company.
  • Reviewing monitoring visit reports, identification of and tracking significant project issues at investigative sites and providing appropriate follow up and documentation to resolution.
  • Reviewing of protocols and clinical development documents with regard to feasibility and logistics of implementation.
  • Evaluating, managing and establishing oversight procedures for CROs.
  • Providing oversight and financial management to forecast and track expenditure in alignment with approved budget.

Job Qualifications


Who You Are

  • You will possess a RN/BA/BS with a minimum of 5 years’ experience (or demonstrated equivalence) in clinical research and a thorough understanding of FDA, ICH and GCP guidelines, as well as strong understanding of cross-functional clinical processes.
  • Must have experience running or working in oncology studies, hematology is a plus.
  • Demonstrated an ability to anticipate potential study execution issues and be able to prepare suitable contingency plans with minimal oversight.
  • Strong clinical project management skills required.
  • Experience of Phase 3 studies will be particularly valuable and desired.
  • Must possess excellent communication skills as well as the ability to manage and organize complex trial execution duties.



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