Clinical Research Scientist
Aequor Information Technologies Pvt. Ltd.
We are seeking a hands-on Clinical Research Scientist with strong experience in oncology clinical drug development to support the day-to-day scientific and operational execution of ongoing clinical trials.
The ideal candidate will have direct experience in end-to-end clinical database review, clinical data cleaning, safety and efficacy assessments, patient monitoring, and clinical study documentation.
This is an execution-focused position requiring someone who can independently manage clinical study activities, identify and resolve data-related issues, and collaborate with cross-functional teams to ensure study quality, patient safety, and protocol compliance.
This is not a biomarker/translational research, laboratory-based, regulatory affairs, or strategic oversight position.
Key Responsibilities
Clinical Trial Execution & Monitoring
- Support the daily execution of Phase I–III oncology clinical trials, ensuring adherence to study protocols and timelines.
- Review patient enrollment, patient-level clinical data, protocol deviations, and ongoing study activities.
- Address site inquiries, patient-related issues, and clinical monitoring concerns in collaboration with Medical Directors and Clinical Operations.
- Independently manage assigned clinical study responsibilities across multiple projects.
Clinical Data Review & Cleaning
- Perform end-to-end clinical database reviews, including safety, efficacy, laboratory, and patient-level clinical data.
- Review EDC systems and clinical data listings to identify inconsistencies, missing information, and potential safety concerns.
- Coordinate with Data Management and clinical teams to investigate discrepancies, resolve queries, and support database cleaning and readiness.
- Analyze clinical data to identify emerging trends, risks, and potential protocol compliance issues.
Clinical Documentation & Scientific Support
- Author, review, and contribute to clinical study protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), and other scientific documents.
- Support the preparation of DSURs, regulatory submissions, and scientific publications, as applicable.
- Interpret clinical safety and efficacy findings to support study decisions, risk assessments, and clinical development milestones .
Cross-Functional Collaboration
- Work closely with Medical Directors, Medical Monitors, Clinical Operations, Data Management, Biostatistics, Pharmacovigilance, and Medical Writing.
- Provide timely clinical study updates, identify potential risks, and recommend appropriate corrective actions.
- Collaborate with global study teams while independently managing daily operational priorities.
Required Qualifications
- 3–5 years of drug development experience within the pharmaceutical or biotechnology industry.
- Minimum 2 years of hands-on oncology clinical development experience; hematology-oncology experience strongly preferred.
- Demonstrated experience directly supporting the execution of clinical trials, rather than primarily performing biomarker, translational, or laboratory research.
- Proven ability to independently conduct comprehensive clinical database reviews, including safety, efficacy, and patient-level data.
- Hands-on experience with EDC systems, clinical data listings, data cleaning, and query resolution.
- Experience reviewing patient enrollment, protocol deviations, clinical monitoring findings, and study-related issues.
- Experience contributing to clinical study protocols, CSRs, IBs, or other core clinical documents.
- Strong clinical data interpretation, scientific communication, problem-solving, and cross-functional collaboration skills.
- Ability to work independently, manage multiple projects, and adapt quickly to changing study priorities.
- Willingness and ability to meet the required hybrid on-site schedule.
Preferred Qualifications
- MS, PhD, PharmD, or other relevant advanced life sciences degree.
- Direct experience in hematology-oncology clinical trials.
- Experience with sponsor-side clinical study execution and coordination.
- Familiarity with Phase I–III clinical drug development.
- Experience contributing to NDA/MAA submissions, DSURs, or scientific publications
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