150 Medical Research jobs in Trivandrum

Work Hours:U.S. time zones – requires evening/night shifts in India

DAVA Oncology is a fast-growing oncology-focused consulting company headquartered in Dallas, Texas. We are recruiting for a Medical Writer and Research Analyst to join our team remotely from India . This is a fully remote position , but working hours will be based on U.S. time zones , meaning evening and night shifts will be required.

Our team members have the opportunity to work in a variety of areas, including but not limited to: clinical trial research and communications, drug or trial publication research and review, and oncology conference meeting reviews. Candidates with previous experience in the oncology therapeutic area are highly desirable.

Responsibilities:

• Conduct secondary research and acquire information from internet sources, compiling it into content.
• Interpret, analyze, and compile proprietary data in a way that delivers a compelling scientific story.
• Research, write, edit, and proof protocols, reports, and publications .
• Maintain a strong scientific understanding of oncology (or the ability to quickly gain such understanding).
• Prepare materials for major cancer conferences and internal oncology meetings .

Qualifications:

• At least 1 year of experience in oncology-focused research or writing is preferred; publication planning experience is a plus.
• Ph.D. in biology, biochemistry, organic chemistry, immunology, molecular biology, biotechnology, Pharm.D. , or other related fields.
• M.S. degree holders in the above fields with exceptional experience will also be considered.
• Authorship in prestigious, peer-reviewed journals is highly preferred.
• Experience in planning, writing, and reviewing study designs, protocols, data analysis, study reports, and regulatory documents is a plus.
• Industry experience (pharmaceutical companies, CROs, etc.) is highly preferred.

Skills & Proficiencies:

• Must be available to work during U.S. business hours (evening/night shifts in India).
• Strong written and oral communication skills ; ability to explain technical concepts clearly.
• Advanced knowledge of Microsoft Office Suite .
• Ability to work independently and collaboratively on multiple projects with tight deadlines.
• Highly motivated, organized, and detail-oriented self-starter.
• Availability to work U.S. hours (evening/night shifts in India).

• Design and develop clinical trial protocols, including study objectives, endpoints, and statistical plans.
• Oversee the execution of clinical trials, ensuring compliance with GCP and regulatory guidelines.
• Manage relationships with investigational sites, Contract Research Organizations (CROs), and other external partners.
• Interpret and analyze complex clinical data, identifying trends and drawing scientifically sound conclusions.
• Author clinical study reports, manuscripts for publication, and regulatory submission documents.
• Collaborate with cross-functional teams, including medical monitors, statisticians, and regulatory experts.
• Contribute to the scientific strategy and pipeline development for new drug candidates.
• Present scientific findings at internal meetings and external conferences.
• Stay abreast of scientific advancements, therapeutic areas, and competitor activities.
• Ensure the safety and well-being of study participants throughout the trial process.

• Ph.D. or Master's degree in a Life Science discipline (e.g., Pharmacology, Biology, Biochemistry, Medicine).
• Minimum of 5-7 years of experience in clinical research within the pharmaceutical or biotechnology industry.
• Proven experience in clinical trial design, execution, and data analysis.
• In-depth knowledge of Good Clinical Practice (GCP) and regulatory requirements (e.g., FDA, EMA).
• Strong scientific writing and communication skills, with a track record of publications and presentations.
• Experience with statistical analysis and interpretation of clinical data.
• Ability to work effectively in a hybrid work environment and collaborate with diverse teams.
• Excellent project management and organizational skills.
• Demonstrated ability to critically evaluate scientific literature and data.
• Experience in specific therapeutic areas relevant to the company's pipeline is a plus.

• Site selection, initiation, monitoring, and close-out visits.
• Ensuring compliance with study protocols, standard operating procedures (SOPs), and regulatory guidelines (e.g., FDA, ICH GCP).
• Verifying the accuracy and completeness of source documents and case report forms (CRFs).
• Managing study supplies and investigational product at clinical sites.
• Serving as the primary point of contact for investigators and site staff.
• Resolving data discrepancies and ensuring timely query resolution.
• Preparing and submitting regulatory documentation as required.
• Identifying and reporting adverse events and serious adverse events (SAEs) in a timely manner.
• Conducting data reviews and audits to ensure data integrity.
• Maintaining accurate and up-to-date trial documentation in electronic trial master files (eTMF).
• Building and maintaining strong working relationships with study personnel, ethics committees, and regulatory authorities.
• Troubleshooting and resolving site-specific issues to ensure smooth trial conduct.
• Contributing to the development and review of study-related documents, such as protocols and informed consent forms.
• Participating in team meetings and providing regular updates on site progress and challenges.

• Bachelor's degree in a life science, nursing, or a related field. A Master's degree is preferred.
• Minimum of 3-5 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotechnology industry.
• In-depth knowledge of clinical trial processes, GCP, and regulatory requirements.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Excellent understanding of medical terminology and data management principles.
• Strong organizational and time-management skills, with the ability to manage multiple projects simultaneously.
• Exceptional interpersonal and communication skills, both written and verbal.
• Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel to study sites as required.
• A proactive and problem-solving attitude.

• Conduct on-site and remote monitoring visits to clinical trial sites according to the Clinical Monitoring Plan.
• Verify the accuracy, completeness, and integrity of clinical data by reviewing source documents and case report forms (CRFs).
• Ensure compliance with study protocols, SOPs, GCP, and applicable regulatory requirements.
• Assess the eligibility of potential participants and monitor their progress throughout the trial.
• Provide training and ongoing support to site staff on study-specific procedures and regulatory compliance.
• Manage site relationships, foster open communication, and address any issues or concerns promptly.
• Prepare monitoring visit reports and follow up on action items to ensure resolution.
• Oversee drug accountability and investigational product management at study sites.
• Facilitate site audits and regulatory inspections.
• Contribute to the development of study-related documents, such as protocols and informed consent forms.
• Ensure timely reporting of adverse events and serious adverse events.
• Maintain organized and up-to-date trial master files (TMF).

• Conduct site selection, initiation, monitoring, and close-out visits.
• Ensure compliance with study protocols, GCP, and regulatory requirements.
• Verify the accuracy and completeness of clinical trial data.
• Manage investigational product accountability and drug dispensing.
• Train and educate site staff on study procedures.
• Resolve site-specific issues and ensure timely resolution of queries.
• Maintain essential study documents and records.
• Prepare monitoring visit reports and action items.
• Communicate effectively with investigators, site staff, and the internal project team.

• Bachelor's degree in a life science, nursing, or a related field.
• Minimum of 5 years of experience as a Clinical Research Associate.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Proven experience in monitoring clinical trials across various therapeutic areas.
• Excellent organizational, time management, and communication skills.
• Ability to travel to clinical trial sites.
• Proficiency in clinical trial management software.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
• Minimum of 3 years of experience as a Clinical Research Associate.
• Thorough understanding of ICH-GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA).
• Proven experience in remote monitoring and site management.
• Excellent communication, interpersonal, and organizational skills.
• Ability to work independently with minimal supervision and manage multiple priorities.
• Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Strong analytical and problem-solving abilities.
• Detail-oriented with a commitment to accuracy and quality.
• Willingness to travel for essential on-site visits if required by specific study protocols (though the role is predominantly remote).
• A proactive approach to identifying and resolving study-related issues.

• Conduct site selection visits to assess the suitability of potential clinical trial sites.
• Initiate, monitor, and close-out clinical trial sites according to Good Clinical Practice (GCP) guidelines and protocol requirements.
• Ensure accurate and timely collection of clinical data, verifying source documentation against case report forms (CRFs).
• Manage investigational product accountability at trial sites.
• Oversee patient recruitment and retention efforts at study sites.
• Train site personnel on study protocols, procedures, and regulatory requirements.
• Serve as the primary point of contact between the sponsor and study sites.
• Ensure compliance with all applicable regulatory requirements, including those of the Indian regulatory authorities.
• Identify and report adverse events and serious adverse events promptly.
• Prepare and submit monitoring visit reports in a timely manner.
• Participate in Investigator Meetings and other relevant site meetings.
• Build and maintain strong relationships with investigators and site staff.
• Contribute to the development of study protocols and clinical trial plans.
• Ensure all study-related documentation is maintained in compliance with GCP and company SOPs.
• Perform risk-based monitoring activities to identify and mitigate potential issues.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
• Minimum of 5 years of experience as a Clinical Research Associate or in a similar clinical research role.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials in India.
• Proven experience in monitoring multiple clinical trials across different therapeutic areas.
• Excellent understanding of pharmaceutical drug development process.
• Strong communication, interpersonal, and negotiation skills.
• Ability to manage time effectively and prioritize tasks in a dynamic environment.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel extensively to clinical trial sites as required by the hybrid model.
• Strong attention to detail and organizational skills.
• Familiarity with data analysis and interpretation for clinical studies is an advantage.
• Experience within the pharmaceutical sector, particularly in the development of novel therapeutics, is preferred for opportunities in Thiruvananthapuram, Kerala, IN .