Study Start Up Professional

3 days ago


Karachi, Sindh, Pakistan Dmclinicalresearch Full time

About This Opportunity

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We are seeking a highly skilled Study Start Up Specialist to join our team at Dmclinicalresearch. As a key member of our project management team, you will be responsible for managing 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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  1. Develop strong relationships with Sponsors/CRO's & Key Stakeholders for study start up activities.

  2. Prepare and prioritize correspondence via email to sponsor level, ensuring timely communication and responsiveness.

  3. Maintain a comprehensive knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents and study protocols, staying up-to-date on relevant changes and updates.

  4. Ensure the handling of sensitive and confidential information with utmost discretion, maintaining confidentiality and integrity.

  5. Participate in and/or lead study start up team meetings as necessary, fostering open communication and collaboration among team members.

  6. Utilize Study Start Up platforms to track activities, develop reports, and analyze data, providing valuable insights to inform decision-making.

  7. Support the on-site clinical operations team with start-up activities, providing study startup updates to management and site staff, and facilitating effective communication.

  8. Monitor Study Start Up Timelines, tracking all startup milestones, meeting deadlines, and driving outcomes follow-up with applicable stakeholders to ensure resolution.

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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