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Associate Manager, Clinical Operations

Cambridge, Massachusetts

Post Date: 12/06/2017 Job ID: 1661 Job Category: Clinical: Clinical Operations and Development

Leads all aspects of a particular clinical study and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities

Works to ensure adherence to a standardized approach to project management

Manages clinical trials projects through leadership of and delegation to a cross-functional study execution team (CST), working under the guidance and direction of an Associate Director, Program Lead.  May rely upon Senior Clinical Project Managers for guidance but acts as a mentor/coach to junior staff.

Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters

Job  Responsibilities:
  • Develops a quality control plan for trial master files and then ensures those TMFs are created, maintained, monitored, and closed out on a timely basis
  • Ensures site monitoring reports are accurate and thorough and that metrics are being adhered to
  • Actively participates in the development of department initiatives, including acting as lead on the development /definition of certain SOPs and processes
  • Ensures that an overarching trial cross-functional quality plan is in place
  • Responsible for managing creation, maintenance and close out of TMF activities – e.g. manages Central Lab and ancillary vendors such as IVRS selection, set-up, conduct, and close-out for studies.
  • Oversees and manages vendors (CRO) to ensure that clinical trials are getting the necessary resources and attention the vendor has committed to ensure trial deliverables and performance goals are met.
  • Oversees the development of and adherence to clinical trial project timelines and ensures senior Clin Ops staff, PDT, and FAHs are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
  • Ensures accurate and comprehensive completion of documents needed by Regulatory Affairs; works with RA to establish timeframes and ensure clarity of documentation required; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines
  • Coordinates the relevant and timely exchange of information / materials (e.g., patient enrollment, site selection, and data collection) with other functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
  • Provides regular timely communications to Supply Operations regarding patient enrollment information at sites to support the supply of drug products to patients
  • Ensures that external partnerships (e.g. CRO) are effectively supporting clinical trials, within contracted terms including budget; is the primary point of contact for CRO partners
  • Adheres to clinical trial budgeting process and provides input on process optimization landscape
  • Leads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through close to ensure both internal and external deliverables are on time and on budget
  • Has both an internal and external perspective on clinical trial management; ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity and the competitive Leads cross functional team to ensure timely activation of clinical trials; including risk management and problem-solving
  • Proactively identifies, negotiates and brokers solutions to individual clinical study issues
  • Delegates and oversees the management of certain aspects of project management to CTA and Senior CTA staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters.


Qualifications/ Requirements:
  • BA/BS with 5-7 years progressive experience in clinical operations preferably within the biotech, pharmaceutical, CRO, industry
  • Demonstrates ability to provide input into clinical protocol development.
  • Demonstrates ability to manage and execute clinical studies.
  • Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
  • Experience of managing/overseeing CROs/vendors.
  • As a result of being member and project manager of CST, develops detailed understanding of different departments and functions and interdependencies of the functions.
  • Very strong verbal, written and presentation skills are required.
  • Experience of leading of a matrixed cross-functional team.

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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