485 Oncology jobs in India

Medical Director - Clinical Oncology

Mumbai, Maharashtra Takeda Pharmaceuticals

Posted 4 days ago

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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
**_Objective / Purpose:_**
+ **_Lead and strengthen OTAU R&D capabilities in India_** _to maximize the value for accelerating global innovation and efficiency, in alignment with global OTAU R&D goals._
+ **_Ensure effective oncology operations in India_** _by leveraging local opportunities and overseeing all OTAU Clinical Science activities in India. Be accountable for speed and quality in collaboration with the global OTAU team and if appropriate OTAU-China, OTAU-Japan and other global R&D functions._
+ **_Partner with ISEA and India LOC leaders_** _to enhance enterprise-level efforts for accelerating global clinical trials._
**_Accountabilities:_**
**Lead India R&D Strategy and Execution**
+ Work closely with OTAU GPTs a and Global R&D functions to optimize integrated India development strategy for pipeline assets
+ Monitor overall country performance and support country focused oncology activities e.g. feasibility and site selections to deliver country operational milestones
+ Serve as the internal expert on India's clinical development to inform global development strategy. Collaborate closely with India LOC to execute One Oncology strategy in India including tapping into local expertise and community networks
+ Collaborate and work closely with Oncology GPTs, the Global R&D team and regional teams, as appropriate, for each asset or indications under the remit
+ Engage study investigators to maintain strong interest and focus on Takeda's oncology clinical trials
+ Proactively build and maintain strong investigator networks in India to support current and future trials across Takeda's oncology portfolio in both solid tumors and hematologic malignancies and proactively share with the OTAU and Global teams
+ Build and scale global clinical trial capabilities in India as a key market in collaboration with LOC, Region and Global teams to accelerate Takeda innovation and boost efficiency
**Clinical Development team participation and leadership**
+ Leads the Development Team in India for assigned compounds. In some cases may lead clinical directors or clinical scientist(s) responsible for leading this team with an emphasis on proactively identifying contingencies, risks, and mitigation strategies.
+ Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols in India. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical and constructive evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
+ Responsible for high impact India specific decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as "go/no go" decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need.
**C. Synopsis / Protocol Development, Study Execution, & Study Interpretation**
+ _Leads Oncology Clinical Science activities in India, including protocol development, study execution, and data interpretation._
+ _Serves as an advisor to the clinical scientists involved in these activities, and be accountable to senior company management for the successful completion of underlying objectives. For the assigned compounds, accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals._
+ _Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients._
**Trial Medical Monitoring**
+ _Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compounds in conjunction with_ _Pharmacovigilance._
**External Interactions**
+ _Leads KOL and investigator engagement strategies to support development of assigned compounds, and contributes to regulatory strategy in India_
+ _Provides leadership and serves as an advisor to the other clinical physicians and scientists engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives in India._
**Due Diligence, Business Development and Alliance Projects**
+ _Can be assigned to be responsible for identification and evaluation of potential business development opportunities, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, as assigned. As part of a global due diligence team, assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with BD teams_
+ _As assigned, serves as clinical point of contact for ongoing alliance projects and interfaces with partner to achieve Takeda's strategic goals while striving to maintain good working relationship between Takeda and partner. Provides guidance to clinical scientists who are involved in some of these activities._
**Leadership, Task Force Participation, Upper Management Accountability**
+ _Interacts directly with research division based on pertinent clinical and development expertise and with NPP to provide_ _knowledge/understanding_ _of India market environment. Represents clinical science on high impact/priority task forces across the organization or external to the company._
+ _While currently an individual contributor position, the position may evolve or progress to be responsible in hiring, managing, mentoring, motivating, empowering, developing and retaining staff members to support assigned activities. Drives performance management, career development, and team engagement_
**Lead** **India** **Oncology Clinical Science team**
+ _Build, manage/overs_ _ee_ _and engage the_ _OTAU members in India_
+ _Foster a high-performing team culture with a focus on development, well-being, and alignment with OTAU's mission_
**Serving as Country Matter Expert**
+ _Be a strong advocate for the Takeda ONE Oncology and R&D organizations in_ _India_ _in collaboration with_ _India_ _LOC; serve as local bridge for any future opportunities in engaging_ _India_ _innovation ecosystem_
+ _Point for escalation for resolution of complex country related issues & risk and serve as a site escalation point for oncology investigator concerns_
+ **Lead and develop oncology clinical strategies for India according to business needs as assigned**
**_Education & Competencies:_**
**Education, Experience, Knowledge and Skills:**
+ _MD, combined MD/PhD or internationally recognized equivalent_
+ _Clinical Training in Malignant Hematology and/or Medical Oncology preferred_
+ _Minimum 3 to 5 years of clinical research experience in the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned)._
+ _Minimum of 4 to 5 years of people management experience in a healthcare or life sciences setting is preferred._
+ _Proven success in leading global or regional clinical development teams, including responsibility for multi-regional studies. Experience beyond US/EU is a plus._
+ _Experience with NDA/MAA Submission preferred_
+ _Experience and expertise in clinical trial management and support of marketing authorization in India as required._
+ _Demonstrated ability to lead and manage cross-functional medical, scientific and technical teams_
**Skills**
+ _Superior communication, strategic, interpersonal and negotiating skills_
+ _Ability to anticipate challenges and drive proactive problem-solving_
+ _Ability to drive decision-making within matrixed multi-regional teams_
+ _Diplomacy and positive influencing abilities across diverse cultures_
+ _Solid teamwork, organizational, interpersonal, and problem-solving skills; exercises good judgment with respect to Takeda confidential information and strategies_
+ _Fluent business English (oral and written) and strong medical writing capabilities_
**Knowledge**
+ _Deep understanding of oncology therapeutic areas, including mechanisms of action relevant to assigned compounds._
+ _Strong knowledge of global regulatory and compliance requirements, including but not limited to ICH GCP; awareness of local country requirements is essential._
+ _Familiarity with emerging research trends in designated therapeutic area_
**TRAVEL REQUIREMENTS:**
+ _Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required._
+ _Requires approximately 15 - 25% travel._
**Locations**
Mumbai, India
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
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Clinical Pharmacist - Oncology

390001 Vadodara, Gujarat ₹80000 Annually WhatJobs

Posted 17 days ago

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full-time
Our client is seeking a highly skilled and dedicated Clinical Pharmacist specializing in Oncology to join their reputable healthcare institution in Vadodara, Gujarat, IN . This position is focused on providing expert pharmaceutical care to cancer patients, ensuring the safe, effective, and cost-conscious use of medications. You will work collaboratively with a multidisciplinary oncology team, including physicians, nurses, and researchers, to optimize patient outcomes. The ideal candidate possesses a strong knowledge base in cancer pharmacotherapy, chemotherapy regimens, and supportive care medications. You will be involved in patient education, medication therapy management, and contributing to evidence-based practice within the oncology pharmacy service. Key responsibilities include:
  • Managing and dispensing chemotherapy and other oncology-related medications, ensuring accuracy and compliance with protocols.
  • Providing clinical consultation on drug selection, dosing, and potential interactions for cancer patients.
  • Monitoring patients for adverse drug reactions and managing toxicities.
  • Educating patients and caregivers about their medications, treatment regimens, and side effect management.
  • Participating in multidisciplinary rounds and tumor board meetings to provide pharmaceutical expertise.
  • Developing and implementing protocols for safe and effective use of oncology drugs.
  • Reviewing and approving physician orders for accuracy and appropriateness.
  • Contributing to drug use evaluations and quality improvement initiatives.
  • Staying current with the latest advancements in oncology pharmacotherapy and research.
  • Mentoring pharmacy residents and students in the oncology specialty.
Qualifications:
  • Doctor of Pharmacy (Pharm.D.) degree from an accredited institution.
  • Completion of a PGY1 Pharmacy Residency and a PGY2 Oncology Pharmacy Residency is highly preferred.
  • Current licensure as a Registered Pharmacist in Gujarat.
  • Minimum of 3 years of experience practicing as a clinical pharmacist, with significant experience in oncology.
  • In-depth knowledge of cancer pathophysiology, chemotherapy agents, immunotherapy, and targeted therapies.
  • Excellent understanding of drug compounding, sterile technique, and hazardous drug handling.
  • Strong analytical, problem-solving, and decision-making skills.
  • Exceptional communication and interpersonal skills for effective collaboration and patient counseling.
  • Proficiency in pharmacy information systems and electronic health records.
This is a vital role within the oncology service, offering a challenging and rewarding career opportunity to make a significant impact on the lives of cancer patients. Join our client and be part of a leading healthcare provider committed to excellence in patient care.
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Lead Clinical Pharmacologist - Oncology

751001 Bhubaneswar, Orissa ₹160000 Annually WhatJobs

Posted 17 days ago

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full-time
Our client, a globally recognized pharmaceutical company, is seeking an accomplished Lead Clinical Pharmacologist to join their innovative research division in a fully remote capacity. This senior scientific role is pivotal in designing and executing clinical pharmacology studies, particularly focusing on oncology therapeutics. You will lead the development of dose selection strategies, population pharmacokinetic (PK) modeling, and drug-drug interaction assessments, ensuring the safe and effective use of new cancer treatments. The ideal candidate will possess a deep understanding of PK/PD principles, extensive experience in clinical trial design, and exceptional analytical and leadership skills.

Responsibilities:
  • Design and develop clinical pharmacology strategies for oncology drug candidates, including dose selection, regimen optimization, and study design.
  • Lead the execution of Phase I-III clinical pharmacology studies, ensuring adherence to protocols and regulatory requirements.
  • Perform and interpret population PK/PD analyses, pharmacokinetic/pharmacodynamic (PK/PD) modeling, and simulations.
  • Evaluate drug-drug interactions (DDIs) and guide the development of appropriate labeling recommendations.
  • Collaborate closely with clinical development teams, statisticians, and regulatory affairs to ensure integrated study planning and execution.
  • Contribute to the preparation of regulatory submission documents (e.g., IND, NDA, BLA).
  • Mentor and guide junior clinical pharmacologists and researchers.
  • Stay abreast of the latest advancements in clinical pharmacology, translational science, and oncology therapeutics.
  • Present scientific findings at internal meetings, external conferences, and to regulatory authorities.
  • Ensure compliance with Good Clinical Practice (GCP) guidelines and all applicable regulations.
  • Review and interpret non-clinical pharmacology data to inform clinical development plans.

Qualifications:
  • Ph.D. or Pharm.D. with post-doctoral training in Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline.
  • Minimum of 7-10 years of progressive experience in clinical pharmacology within the pharmaceutical industry, with a strong focus on oncology.
  • Proven expertise in designing and executing clinical pharmacology studies, including dose escalation and PK/PD studies.
  • Extensive experience with population PK/PD modeling and simulation software (e.g., NONMEM, Phoenix WinNonlin).
  • Deep understanding of oncology drug development and relevant regulatory guidelines.
  • Strong knowledge of drug metabolism, drug interactions, and QTc studies.
  • Excellent analytical, scientific, and problem-solving skills.
  • Exceptional written and verbal communication skills, with a demonstrated ability to present complex scientific data effectively.
  • Proven leadership capabilities and experience mentoring scientific staff.
  • Ability to work independently and manage multiple projects in a remote setting.

This is a critical opportunity for a seasoned clinical pharmacologist to significantly impact the development of life-saving cancer treatments for our client, working entirely remotely from their preferred location. The successful candidate will lead key aspects of oncology drug development strategy for our client, contributing vital expertise to their pipeline.
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Clinical Research Scientist - Oncology

110001 Delhi, Delhi ₹1200000 Annually WhatJobs

Posted 1 day ago

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full-time
Join a leading pharmaceutical company as a Clinical Research Scientist specializing in Oncology, based in our Delhi, Delhi, IN research facility. This critical role involves the design, execution, and interpretation of clinical trials aimed at developing innovative cancer therapies. You will work closely with cross-functional teams, including medical affairs, regulatory affairs, and data management, to ensure the successful progression of research projects from concept to completion. The ideal candidate will possess a strong scientific background, in-depth knowledge of oncology, and extensive experience in clinical trial management and biostatistics. Responsibilities include developing clinical trial protocols, selecting investigators and sites, monitoring trial progress, analyzing study data, and preparing regulatory submissions. You will also contribute to the scientific strategy for oncology drug development and stay abreast of the latest advancements in the field. A PhD or Master's degree in a relevant life science discipline (e.g., Biology, Pharmacology, Medicine) is required, along with a minimum of 5 years of experience in clinical research, preferably within the pharmaceutical or biotechnology industry. Excellent analytical, written, and verbal communication skills are essential for collaborating with internal teams and external partners, as well as for authoring scientific publications and presentations. This hybrid role offers a blend of in-office laboratory work and strategic planning, with opportunities for remote data analysis and report writing. We are seeking a highly motivated and detail-oriented individual with a passion for advancing cancer treatment. The ability to manage complex projects, interpret complex scientific data, and navigate regulatory landscapes is crucial. If you are a dedicated scientist looking to make a tangible impact on patient lives through groundbreaking research, we invite you to apply.
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Clinical Research Associate - Oncology

695001 Thiruvananthapuram, Kerala ₹60000 Monthly WhatJobs

Posted 2 days ago

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full-time
Our client is actively seeking a dedicated and meticulous Clinical Research Associate (CRA) with expertise in oncology studies to join their growing pharmaceutical research division. This role is crucial in ensuring the successful execution of clinical trials, adhering to strict regulatory guidelines and ethical standards. As a CRA, you will be responsible for monitoring clinical trial sites to ensure data accuracy, patient safety, and protocol compliance. Your duties will include initiating, monitoring, and closing out clinical investigator sites, conducting source data verification, and resolving data discrepancies. You will liaise closely with investigators, study coordinators, and other site staff, providing training on study protocols and regulatory requirements. Travel to clinical trial sites within the designated region, including **Thiruvananthapuram, Kerala, IN**, and potentially other locations, will be a significant part of this role. You will meticulously review trial documentation, including essential documents, investigational product accountability, and regulatory binders, ensuring compliance with Good Clinical Practice (GCP) guidelines and local regulations. A key aspect of the job involves identifying and reporting adverse events and safety concerns in a timely manner. You will also assist in the preparation of study-related documents and contribute to study progress reports. The ideal candidate will possess a strong understanding of oncology drug development, clinical trial processes, and regulatory frameworks (e.g., FDA, ICH-GCP). Excellent organizational, communication, and interpersonal skills are essential for effectively managing multiple sites and building strong relationships with healthcare professionals. A Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field is required, along with prior experience as a CRA or in a clinical research-related role. Experience in oncology is highly preferred. This hybrid role offers a balance between remote work for documentation and reporting, and on-site visits to clinical trial locations.
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Clinical Research Scientist - Oncology

411001 Pune, Maharashtra ₹90000 Annually WhatJobs

Posted 2 days ago

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full-time
Our client is seeking an experienced Clinical Research Scientist with a specialization in Oncology to join their innovative pharmaceutical team in Pune, Maharashtra, IN . This hybrid role involves a combination of on-site laboratory work and data analysis, with flexibility for remote scientific reporting and literature reviews. You will play a crucial role in designing, executing, and analyzing clinical trials aimed at developing novel cancer therapies. The ideal candidate will have a strong scientific background, a deep understanding of cancer biology, and experience in clinical trial management.

Key Responsibilities:
  • Design and develop clinical trial protocols for oncology therapeutics, ensuring adherence to regulatory guidelines (e.g., ICH-GCP).
  • Oversee the execution of clinical trials, including site initiation, monitoring, and data collection.
  • Analyze and interpret complex clinical trial data, including efficacy, safety, and pharmacokinetic data.
  • Prepare scientific reports, regulatory submissions, and publications summarizing trial results.
  • Collaborate with cross-functional teams, including R&D, regulatory affairs, and medical affairs, to advance drug development programs.
  • Stay updated on the latest advancements in oncology research, therapeutic targets, and competitive landscape.
  • Manage relationships with external investigators, key opinion leaders, and contract research organizations (CROs).
  • Contribute to the strategic planning of clinical development programs.
  • Ensure compliance with all ethical and regulatory requirements throughout the trial lifecycle.
  • Present research findings at scientific conferences and meetings.
A Ph.D. or Master's degree in a relevant life science discipline (e.g., Oncology, Pharmacology, Molecular Biology) is required. A minimum of 5 years of experience in clinical research, preferably within the pharmaceutical industry and in oncology, is essential. Proven experience in protocol development, clinical trial management, and data analysis is mandatory. Excellent scientific writing and communication skills are crucial. Familiarity with regulatory requirements and guidelines for drug development is expected. This hybrid position offers the chance to contribute significantly to life-saving research while benefiting from a flexible work arrangement within the vibrant city of Pune, Maharashtra, IN .
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Clinical Research Scientist - Oncology

400601 Thane, Maharashtra ₹1300000 Annually WhatJobs

Posted 3 days ago

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full-time
Our client is a leading pharmaceutical company seeking a highly motivated and experienced Clinical Research Scientist specializing in Oncology to join their innovative research and development team. This critical role will contribute to the design, execution, and interpretation of clinical trials focused on novel cancer therapies. You will be instrumental in advancing our understanding of oncological diseases and developing life-saving treatments. Responsibilities include developing clinical trial protocols, assessing investigational drug efficacy and safety, and analyzing clinical data to inform strategic decisions. You will collaborate closely with internal teams (e.g., medical affairs, regulatory affairs, statistics) and external partners (e.g., investigators, site staff, CROs) to ensure the successful conduct of trials. A key aspect of this position is staying abreast of the latest scientific advancements, emerging trends, and regulatory requirements in oncology drug development. The ideal candidate will possess a strong scientific background, deep knowledge of cancer biology and clinical trial methodologies, and excellent analytical and communication skills. Experience in data management, statistical analysis, and report writing is essential. This role requires a meticulous approach to research, a commitment to scientific integrity, and the ability to translate complex scientific information into actionable insights. You will contribute to the strategic direction of clinical development programs, ensuring alignment with the company's overall R&D objectives. This is an excellent opportunity for a dedicated scientist to make a significant impact on patient care and the future of cancer treatment within a supportive and collaborative environment.

Responsibilities:
  • Design, implement, and manage clinical trials in oncology.
  • Develop clinical trial protocols and study documents.
  • Oversee data collection, analysis, and interpretation for clinical studies.
  • Evaluate drug safety and efficacy based on clinical trial results.
  • Collaborate with investigators, clinical research associates, and other site personnel.
  • Liaise with regulatory authorities and ethics committees.
  • Prepare scientific reports, publications, and presentations.
  • Stay current with scientific literature and advancements in oncology research.
  • Contribute to the strategic planning of clinical development programs.
  • Ensure compliance with Good Clinical Practice (GCP) and other regulatory guidelines.
Qualifications:
  • Ph.D. or M.D. in Life Sciences, Pharmacology, Medicine, or a related field.
  • Minimum of 5 years of experience in clinical research, specifically in oncology.
  • In-depth knowledge of cancer biology, disease mechanisms, and therapeutic approaches.
  • Experience in designing and managing Phase I-IV clinical trials.
  • Strong understanding of statistical analysis and data interpretation.
  • Proficiency in clinical data management systems and regulatory requirements.
  • Excellent written and verbal communication skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work effectively in a cross-functional team environment.
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Clinical Research Scientist, Oncology

600001 Chennai, Tamil Nadu ₹120000 Annually WhatJobs

Posted 7 days ago

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Job Description

full-time
Our client, a leading pharmaceutical innovator, is seeking a talented and motivated Clinical Research Scientist specializing in Oncology to join their dynamic team. This role offers a hybrid work model, allowing for a blend of in-office collaboration and remote flexibility. You will play a crucial role in the design, execution, and analysis of clinical trials for novel cancer therapies, contributing to groundbreaking advancements in patient care. The ideal candidate will possess a strong scientific background, meticulous attention to detail, and a deep understanding of oncology drug development.

Responsibilities:
  • Contribute to the development and refinement of clinical trial protocols, study plans, and Investigator's Brochures.
  • Oversee and manage the conduct of clinical trials, ensuring compliance with GCP, regulatory guidelines, and ethical standards.
  • Analyze clinical data, interpret results, and prepare comprehensive study reports.
  • Collaborate with cross-functional teams, including medical affairs, regulatory affairs, data management, and clinical operations.
  • Liaise with investigators, study coordinators, and clinical research organizations (CROs) to ensure smooth trial execution.
  • Review and interpret safety data, identifying potential risks and implementing mitigation strategies.
  • Contribute to the preparation of regulatory submissions and scientific publications.
  • Stay abreast of the latest scientific literature, clinical trial advancements, and regulatory landscape in oncology.
  • Assist in the selection and qualification of clinical trial sites.
  • Present study findings at internal meetings and scientific conferences.
Qualifications:
  • Ph.D. or M.D. in a relevant life science discipline (e.g., Biology, Pharmacology, Medicine).
  • Minimum of 3-5 years of experience in clinical research, preferably within the pharmaceutical industry and in oncology.
  • Strong understanding of oncology drug development processes and clinical trial methodologies.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Proficiency in data analysis and interpretation.
  • Strong knowledge of ICH-GCP guidelines and other relevant regulatory requirements.
  • Excellent written and verbal communication skills, with the ability to present complex scientific information clearly.
  • Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
  • Ability to work effectively in a team environment and manage multiple priorities.
This hybrid position based in Chennai, Tamil Nadu, IN offers a compelling opportunity for a passionate scientist to make a significant impact on the development of life-saving cancer treatments. You will be part of a collaborative and innovative research environment.
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Clinical Research Associate - Oncology

700071 Kolkata, West Bengal ₹750000 Annually WhatJobs

Posted 8 days ago

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full-time
Our client, a leading pharmaceutical company focused on innovative treatments, is seeking a highly organized and dedicated Clinical Research Associate (CRA) to join their oncology research team. This on-site position in Kolkata, West Bengal, IN is crucial for the successful execution of clinical trials that bring life-saving cancer therapies to patients. As a CRA, you will be responsible for monitoring clinical trial sites, ensuring adherence to protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will play a vital role in data integrity, patient safety, and the overall success of our clinical development programs.

Key Responsibilities:
  • Perform site selection, initiation, monitoring, and closing visits in accordance with protocol and regulatory requirements.
  • Verify the accuracy, completeness, and quality of clinical trial data.
  • Ensure compliance with protocol, GCP, and all applicable regulations.
  • Manage communication between the investigative sites and the clinical study team.
  • Train and support site staff on study procedures and data collection.
  • Oversee drug accountability and study supplies at clinical sites.
  • Identify and report adverse events and serious adverse events promptly.
  • Maintain accurate and organized study documentation and files.
  • Participate in investigator meetings and study-related training.
  • Contribute to the development of study protocols and case report forms (CRFs).

Qualifications:
  • Bachelor's degree in Nursing, Pharmacy, Life Sciences, or a related field.
  • Minimum of 3 years of experience as a Clinical Research Associate, preferably in oncology trials.
  • In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
  • Experience with various EDC systems and clinical trial databases.
  • Excellent monitoring and auditing skills.
  • Strong communication, interpersonal, and organizational skills.
  • Ability to travel to clinical sites as required.
  • Attention to detail and a commitment to data accuracy and patient safety.
  • Familiarity with oncology drug development is highly desirable.

This role requires a professional committed to advancing cancer research. The position requires a dedicated presence in our client's office and at clinical sites in and around Kolkata, West Bengal, IN . You will be part of a collaborative team working towards significant breakthroughs in cancer treatment.
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Clinical Research Associate - Oncology

700001 Kolkata, West Bengal ₹650000 Annually WhatJobs

Posted 8 days ago

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Job Description

full-time
Our client, a renowned pharmaceutical company dedicated to advancing cancer treatments, is seeking a highly skilled and motivated Clinical Research Associate (CRA) specializing in Oncology. This position, located in Kolkata, West Bengal , offers a hybrid work arrangement, allowing for effective remote management of study activities alongside essential on-site monitoring and site engagement. You will play a pivotal role in the execution of clinical trials, ensuring compliance with protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. The ideal candidate will possess a strong understanding of oncology, clinical trial processes, and data management. Responsibilities include site initiation, monitoring patient recruitment, data verification, issue resolution, and maintaining accurate study documentation. We are looking for an individual with exceptional attention to detail, excellent communication and interpersonal skills, and a commitment to patient safety and data integrity.

Key Responsibilities:
  • Manage and monitor assigned clinical trial sites to ensure adherence to study protocols, SOPs, and regulatory requirements.
  • Conduct site initiation visits, routine monitoring visits (remote and on-site), and close-out visits.
  • Verify the accuracy, completeness, and integrity of clinical trial data.
  • Ensure timely reporting of adverse events and safety updates.
  • Train and support site personnel on study procedures and requirements.
  • Oversee patient recruitment and retention efforts at study sites.
  • Maintain effective communication with investigators, study coordinators, and internal project teams.
  • Prepare and present study progress reports.
  • Ensure all study-related documentation is maintained in accordance with regulatory standards (e.g., TMF).
  • Troubleshoot and resolve site-specific issues to ensure smooth trial operations.

Qualifications:
  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field.
  • Minimum of 3 years of experience as a Clinical Research Associate, with specific experience in oncology trials.
  • In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
  • Experience with various phases of clinical trials (Phase I-IV).
  • Proficiency in EDC systems and clinical trial management software.
  • Excellent monitoring, auditing, and problem-solving skills.
  • Strong organizational and time management abilities.
  • Exceptional written and verbal communication skills.
  • Ability to work independently and collaboratively in a hybrid work environment.
  • Demonstrated understanding of oncology principles and disease states is crucial.
  • Certification such as CCRP or CRA is a plus.
Join our client's vital mission to develop life-saving cancer therapies. This hybrid role offers a competitive salary, comprehensive benefits, and the opportunity to contribute meaningfully to groundbreaking medical research.
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