9 Phase I jobs in India

• Conduct site selection, initiation, monitoring, and close-out visits in accordance with study protocols and SOPs.
• Ensure compliance with all applicable regulatory requirements, including ICH-GCP, FDA regulations, and local laws.
• Verify the accuracy, completeness, and consistency of clinical data collected at study sites.
• Monitor subject safety and adverse event reporting, escalating issues as necessary.
• Train and support investigators and site staff on study procedures and regulatory requirements.
• Manage communication between study sites, the clinical operations team, and other stakeholders.
• Review and maintain essential regulatory documents, ensuring they are current and accurate.
• Identify, document, and resolve site-level issues and discrepancies.
• Contribute to the development and review of study-related documents, such as protocols and case report forms (CRFs).
• Manage study site timelines and ensure timely completion of study milestones.

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related scientific field. Advanced degree preferred.
• Minimum of 5 years of experience as a Clinical Research Associate, with significant experience in Phase III trials.
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements.
• Proven experience in clinical trial monitoring and site management.
• Excellent communication, interpersonal, and negotiation skills.
• Strong organizational and time management abilities, with a keen eye for detail.
• Ability to work independently and manage a remote workload effectively.
• Willingness to travel up to 60% of the time to assigned clinical sites.
• Proficiency in EDC systems and CTMS.
• Strong problem-solving skills and the ability to make sound judgments.

• Initiate, monitor, and close-out clinical trial sites according to protocol and GCP guidelines.
• Ensure accurate, complete, and timely data collection and entry into clinical databases.
• Verify source data against Case Report Forms (CRFs) and other study documents.
• Conduct site visits (remote and on-site) to assess protocol compliance, data integrity, and patient safety.
• Train site personnel on study procedures, protocol requirements, and regulatory compliance.
• Manage and resolve data queries promptly and efficiently.
• Oversee drug accountability and storage at study sites.
• Prepare and present monitoring reports to the clinical trial manager and other stakeholders.
• Identify potential risks and issues at study sites and implement corrective action plans.
• Maintain effective communication with investigators, study coordinators, and internal project teams.
• Ensure all study-related documentation is maintained in compliance with regulatory requirements and company SOPs.
• Participate in investigator meetings and provide support during regulatory inspections.
• Contribute to the development and review of study-related documents, such as protocols, ICFs, and CRFs.
• Manage study supplies and equipment distribution to sites.

• Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
• Minimum of 3-5 years of experience as a Clinical Research Associate, with significant experience in Phase III trials.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Proven ability to manage multiple sites and projects simultaneously.
• Excellent verbal and written communication skills.
• Strong organizational and time-management abilities.
• Proficiency in clinical trial management systems (CTMS) and Electronic Data Capture (EDC) systems.
• Ability to travel to study sites as required.
• Problem-solving skills and a proactive approach to identifying and resolving issues.
• Team player with the ability to work effectively in a collaborative environment.

• Perform site selection, initiation, monitoring, and close-out visits.
• Ensure compliance with study protocols, SOPs, and regulatory requirements (GCP, FDA).
• Verify data accuracy and completeness by reviewing source documents and CRFs.
• Build and maintain relationships with investigators and site staff.
• Provide training and support to clinical site personnel.
• Manage site-level budgets and expenses.
• Identify and resolve study-related issues and data queries.
• Ensure timely reporting of adverse events.
• Maintain study documentation and regulatory binders.

• Proven experience as a Clinical Research Associate (CRA).
• In-depth knowledge of GCP, FDA regulations, and clinical trial processes.
• Experience with Phase III clinical trials.
• Strong understanding of medical terminology and clinical procedures.
• Excellent monitoring and data management skills.
• Proficiency in clinical trial management software and EDC systems.
• Excellent communication, interpersonal, and problem-solving skills.
• Ability to travel to sites and work independently.
• Bachelor's degree in a life science, nursing, or related field.

Who Are You?

An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead Phase II-III clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what it is but always push clinical development forward to what it could be. You motivate others to do the same.

Sponsor-dedicated:

Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.

Position Overview:

Our Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.

Responsibilities

As a Principal Biostatistician, your responsibilities will include:

• Provide statistical input into study protocols, Case Report Forms, and data management plans, DMCs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Incorporate Estimand framework while authoring study documents.
• Create specifications and perform analyses such as time-to-event and longitudinal analysis.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
• When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
• Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

Qualifications

Here at Cytel we want our employees to succeed, and we enable this success through consistent training, development and support. To be successful in this position you will have:

• PhD in statistics or master’s degree in statistics or related subject required along with clinical trial experience.
• Relevant experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma/biotech industry preferred.
• Understanding of the application of biostatistics to medical/clinical trials data.
• Excellent verbal and written communications skills.
• Ability to organize multiple work assignments and establish priorities
• Working SAS & CDISC knowledge required. Experience in R/R Shiny is preferred.
• Late Phase (II or III) experience required. Experience with regulatory submissions is a plus.
• Adaptive design, Estimand framework, EAST experience preferred.

Why Multi Phase Power

MPP product line offers high performance, innovative and cost-effective power solutions for a broad range of customer applications in enterprise, communications and automotive which include multiple phase DC/DC controllers, smart power stages. In MPP, our mission is to power the processors that power AI & future servers. Target platforms include Intel, AMD, ARM, NVidia and custom ASIC/FPGAs from various vendors.

We are looking for an Analog Design Lead / Senior Design Engineers who have the passion and excitement to grow, innovate, take an active role in designing high current Power stage ICs. This is a fast paced, results driven environment that requires broad knowledge, creativity and excellent interpersonal skills on a daily basis. The engineers have to collaborate with the broader IC development teams (Layout, DV, Test, System Validation & Product Engineers) to deliver products to the market which are compelling, competitive, cost-conscious, manufacturable, and importantly, successful in growing TI's business

Basic Qualifications:

Bachelor's/Master's Degree in EE

5+ Years experience in Analog Design

Basic Job Qualifications:

• Strong competency in transistor level design and implementation of various Analog functions.
• Strong track record of taping out multiple complex IPs to manufacturing.
• Experience in designing analog circuits like operational amplifiers, Band-gap references, comparators, chargepump, level shifters.
• Experience on working with digital designers, providing and defining specs and state machine
• Experience on leading a full chip development /owning a sub-system for a complex chip.
• Top-level integration, Block-level verification across PVT, Statistical Mismatch, layout guidance.
• Strong silicon debugging skill to solve complex silicon problems through simulation and bench testing.
• Good communication, presentation skills and should be a team player.

Preferred qualification:

• Experience on BCD process is a plus.
• Experience in switching DC-DC converter design, buck, buck-boost, control loop is preferred.
• Experience on design and layout of gate drivers, LDMOS, fault systems is highly desirable.
• Understanding of chip level ESD/LU, EM requirements.
• Good knowledge of IC Packaging and production test methodologies.

Primary responsibilities:

• Lead the full chip development with product ownership from definition to release to manufacturing.
• Work closely with marketing and systems teams to define product specifications.
• Work closely with other designers and technologist in defining various architecture.
• Derive block level specification and select the topology based on product requirements.
• Generate top-level simulation plan and collaborate with verification engineer for best coverage.
• Work closely with Layout engineer to get optimized IC layout by minimizing parasitic elements.
• Validate Silicon, assist characterization and participate in De-bug process
• Mentor 1-2 people

• Conducts site visits (initiation, interim, and close-out) to monitor study conduct and ensure compliance with protocols, SOPs, and GCP.
• Verifies the accuracy, completeness, and integrity of clinical data through source data verification.
• Ensures timely reporting of study progress, issues, and resolutions to the project team.
• Manages communication between investigative sites and the sponsor.
• Assists in site selection and qualification processes.
• Reviews essential regulatory documents and maintains accurate site files.
• Identifies and resolves site-level issues and discrepancies.
• Provides training and ongoing support to study coordinators and investigators.
• Ensures adherence to safety reporting requirements.
• Contributes to the overall success of clinical trial execution by meeting study timelines and quality standards.

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 3-5 years of experience as a Clinical Research Associate (CRA) or in a similar clinical research role.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Proven experience in monitoring Phase III clinical trials.
• Excellent understanding of clinical trial processes, including site initiation, monitoring, and close-out.
• Strong data verification and problem-solving skills.
• Exceptional written and verbal communication skills.
• Ability to manage multiple sites and prioritize tasks effectively.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Must possess a valid driver's license and be willing to travel to clinical sites as required.

Business Development Manager - Clinical Research - Phase 4 studies

Location : Mumbai/ Bangalore

Role Summary:

We are seeking a dynamic and results-driven Business Development Manager to lead our clinical research services. The ideal candidate will be responsible for identifying and securing new business opportunities, fostering long-term client relationships, and establishing strategic alliances to support sustained growth in the clinical research (Late Phase Studies).

Key Responsibilities:

• Proactively identify and pursue new business opportunities in clinical research (Late Phase Studies).

• Establish and nurture strong relationships with key decision-makers and stakeholders.

• Conduct in-depth market research to analyze industry trends, competitive dynamics, and emerging growth areas.

• Develop, tailor, and present compelling proposals, project plans, and pricing models to prospective clients.

• Work closely with internal teams—clinical operations, project management, and data management—to ensure successful and timely project execution.

• Represent the company at industry conferences, trade shows, and networking events to enhance visibility and foster new partnerships.

• Track and analyze sales performance metrics, delivering actionable insights and strategic recommendations.

• Drive initiatives to strengthen brand recognition and broaden market reach.

Qualifications:

• Bachelor's or Master’s degree in Life Sciences, Business Administration, or a related discipline.

• Minimum of 7 years of experience in business development or sales within the clinical research industry.

• Strong knowledge of clinical trial workflows, regulatory frameworks, and industry best practices.

• Demonstrated success in meeting or exceeding sales targets and contributing to business growth.

• Exceptional communication, negotiation, and presentation skills.

• Self-motivated and team-oriented, with the ability to thrive in a fast-paced, dynamic environment.