Senior Clinical Trial Associate

1 month ago

Cambridge, United States ONO PHARMA USA Full time

Role responsible for collaborating with and utilizing instructions/information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effective implementation and maintenance of the clinical operational study documentation, in accordance with study timelines from study initiation through to study closeout. The role:


  • Prepares, processes, distributes, updates and maintains (filing and archiving) clinical study documentation in an electronic format. Ensures study compliance with OPUS SOPs and regulatory guidelines. Ensures TMF/eTMF is FDA-inspection ready at all times while the clinical trial is being conducted.
  • Creates a documentation system (document files, binders, manuals, etc.) chronicling all incoming/outgoing clinical documentation. Provides oversight of Regulatory documents for site activation.
  • Tracks study progress including site contracts, patient enrolment and patient status, and provides QC oversight of the CRO, TMF, QV Reports, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.


Planning and Execution

  • Schedules Clinical Operations, study team, investigator and partner meeting, preparing/distributing required materials, and taking and distributing minutes, as required.
  • Contributes to the 3rd party vendor qualification process (e.g. getting their financial condition utilizing a specific vendor, checking if there is an unacceptable risk of bribery or corruption using a specific checklist).
  • Creates and/or reviews the study plans, specification documents, materials, and tools.


Financial Outcome

  • Creates and maintains project databases (e.g., contact list, competitive study list), facilitates and tracks study payments following the internal approval process.
  • Processes and tracks payments to vendors and study sites as appropriate. May be required to perform other duties, as assigned.


Operation and Improvement

  • Prepares, processes, distributes, updates and maintains (filing and archiving) clinical study documentation in an electronic format. Ensures study compliance with OPUS SOPs and regulatory guidelines by performing periodic quality control audits of any trial master file (TMF) maintained by the Service Provider (SP) before study initiation, during and at the end of a study. Ensures TMF/eTMF is FDA-inspection ready at all times while the clinical trial is being conducted. Provides access to the systems when applicable.
  • Creates a documentation system chronicling all incoming/outgoing clinical documentation, maintains study supply documentation, reviews Study Folder regularly to ensure file accuracy and completeness, maintains study specific metric tracking and reviews Clinical Research Associate (CRA) field monitor reports and any necessary follow-up letters in relation to specific Study Monitoring Plan, contacting CROs and CRAs, as required. Provides oversight of Regulatory documents for site activation.
  • Tracks study progress including site contracts, patient enrolment and patient status, and provides QC oversight of the CRO, TMF, QV Reports, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
  • Contributes to the development and updating of Clinical Operations SOPs and ensuring contribution to Clinical Operations process improvement within the clinical operations team and OPUS in general.


Innovation

  • Keeps abreast of the broad context of the industry related to commercial operations, regulations, best practices, relevant technologies and innovations. Understands the implications for the assigned area and implements innovative operations approaches to help ensure efficient operations and achieve mandate.


Talent Development and Organization Growth

  • Tracks and ensures training of the study team.


External/Internal Relationship

  • Perform administrative tasks associated with the CTA role and responsibilities, as well as supporting other clinical operations team members.


Educational Requirements

  • Associate’s Degree, or the equivalent in work experience, preferably in the life sciences.


Experience

  • 3+ years of clinical trial management experience in the pharmaceutical/biotechnology industries, or with a Clinical Research Organizations (CROs) or a clinical research site
  • 1+ years of Clinical Operations work experience.
  • Knowledge and experience creating, organizing and maintaining eTMFs.


Technical Skills

  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), email and internet.
  • Knowledge of the Pharmaceutical Industry Clinical trial process (clinical trial conduct, documentation and reporting) in accordance with ICH/GCP and other regulatory compliance guidelines.


Cognitive Skills

  • Problem solving capabilities to align with independent assignments requiring limited supervision.
  • Demonstrated ability to effectively manage and problem-solve several complex studies with rigorous timelines; provides high quality work resulting from attention to detail and accuracy; successfully interacts and communicates with multiple internal and external process owners.


Language/Interpersonal Skills

  • Strong verbal and written communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams so as to build commitment.


Physical Demands

  • Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting/moving up to 15 pounds (e.g., in order to shred documents, to maintain a neat and organized work environment, and to lift paper supplies, and large boxes and files).


Work Environment

  • The noise level in the work environment is usually quiet.


Business Travel

  • This role may require the incumbent to occasionally travel (domestic) to attend meetings. Travel will be scheduled based upon the needs of the business.


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role. (US Only)

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