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Lead-Remote Monitoring

5-8 years
Not Disclosed
1 Dec. 10, 2024
Job Description
Job Type: Full Time Education: B.Pharm / M.Pharm / M.Sc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Lead - Remote Monitoring

Experience Required: 5–8 Years
Educational Qualification: B.Pharm / M.Pharm / M.Sc
Location: Ahmedabad


Job Description

We are looking for an experienced Lead - Remote Monitoring to join our clinical research team. This position will be responsible for overseeing and leading remote monitoring activities for clinical trials, ensuring compliance with regulatory requirements, and ensuring optimal data quality throughout the trial process. The successful candidate will have a strong background in clinical research monitoring, as well as leadership experience.


Key Responsibilities

  • Lead Remote Monitoring: Oversee and manage the remote monitoring team, ensuring effective and efficient monitoring of clinical trials in accordance with regulatory guidelines and the study protocol.

  • Study Protocol Adherence: Ensure all trials follow Good Clinical Practice (GCP), ICH guidelines, and all relevant regulatory requirements.

  • Collaboration: Work closely with cross-functional teams, including clinical operations, project managers, and investigators, to ensure smooth execution and management of remote monitoring activities.

  • Data Quality Assurance: Review and verify data to ensure compliance with study protocol and regulatory standards. Address data issues and resolve any discrepancies promptly.

  • Training and Mentoring: Provide training, mentoring, and support to junior remote monitoring staff, ensuring they are equipped with the necessary tools and knowledge to perform their roles.

  • Reporting and Documentation: Oversee the generation and submission of accurate and timely reports, including monitoring visit reports and any corrective action reports.

  • Client Interaction: Serve as the primary point of contact for clients on remote monitoring issues, ensuring client expectations are met and providing status updates as needed.

  • Resource Management: Ensure appropriate resource allocation for remote monitoring activities, assess resource needs, and assist in project planning and forecasting.

  • Problem-Solving: Proactively identify potential issues in remote monitoring and data collection, developing strategies to mitigate and resolve them efficiently.


Candidate Requirements

  • Educational Background:

    • B.Pharm / M.Pharm / M.Sc in Life Sciences or a related field.

  • Experience:

    • 5–8 years of experience in clinical research, including remote monitoring or clinical trial management.

    • Strong background in remote monitoring of clinical trials and knowledge of clinical operations.

  • Leadership Experience:

    • Previous experience leading or managing a team, with the ability to provide guidance, mentorship, and training to junior staff.

  • Knowledge and Skills:

    • In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.

    • Excellent understanding of clinical trial processes, data integrity, and monitoring methodologies.

    • Strong organizational, problem-solving, and time management skills.

    • Excellent communication skills, both written and verbal.

  • Technical Skills:

    • Familiarity with clinical trial management systems (CTMS), remote monitoring platforms, and other relevant software tools.

  • Certifications (Preferred):

    • Relevant certifications in clinical research or remote monitoring (e.g., ACRP, SOCRA).


Why Join Us?

  • A leadership role with the opportunity to make an impact on high-priority clinical trials.

  • Competitive compensation package with growth opportunities.

  • Work with an innovative team and contribute to advancing clinical research globally.

  • A collaborative and dynamic work environment.

  • Access to continuous professional development and training to support career progression.

If you are passionate about clinical research and have experience leading remote monitoring teams, apply for the Lead - Remote Monitoring position in Ahmedabad and help drive clinical trials to success!