Clinical Operations Manager

3 days ago


Karachi, Sindh, Pakistan Dmclinicalresearch Full time

About the Role

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As a Study Start Up Specialist at Dmclinicalresearch, you will be an integral part of our project management team. Your primary responsibility will be to manage the portfolio of active and future studies in our pipeline, including bringing pipeline opportunities to activation within defined timelines. You will also be involved in process improvement strategies for all stakeholders.

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Key Responsibilities

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  • Develop/maintain positive relationships with Sponsors/CRO's & Key Stakeholders for study start up activities.
  • Prepare and prioritize correspondence via email to sponsor level.
  • Maintain a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents and study protocols.
  • Handle sensitive and confidential information with discretion.
  • Prepare, participate and/or lead study start up team meetings as appropriate.
  • Utilize Study Start Up platforms to track activities and develop reports.
  • Support the on site clinical operations team with start up activities and provide study startup updates to management and site staff.
  • Observe, disseminate & promote Study Start Up Timelines, monitoring all startup milestones, and meeting deadlines, and drive outcomes follow-up with applicable stakeholders to ensure resolution.
  • Reporting project status and issues to Senior Project Manager on a regular basis.
  • Assist in Sponsor/CRO vendor management for site readiness.
  • Act as a subject matter expert on all SSU related activities, overseeing and leading activation activities.

Requirements

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  • A minimum of 3+ years of clinical research experience.
  • Experience with ICH/GCP documentation and process preferred.
  • Experience working in the clinical research industry and knowledge of the clinical trials process required.
  • Experience in Study Start-Up activities, activation, supplies & accesses delivering high quality work in a dynamic environment.

Working Conditions

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Flexible and willing to provide cross-functional support. Ability to manage multiple tasks simultaneously and meet deliverables deadlines in accordance with Study Start-Up timelines. Be detail-oriented and demonstrate attention to detail with ability to use critical thinking skills to proactively identify and solve problems. Excellent oral and written communications skills. Strong presentation, documentation and interpersonal skills. Proficient computer skills including Word, Excel (Advanced), Power Point, Adobe Software and Google Sheets. Strong prioritization and time management skills.



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