11 Medical Monitoring Jobs

Minimum 1 year experience in respective field Share the cv to recruitment@meditrinahospital.com 7736485552

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Department-Centralised Monitoring Unit (CMU) Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment. About the department The Centralised Monitoring Unit (CMU)- Bangalore, is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform the detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials. The Position: (NoteThis is not a role within Pharmacovigilance) The Senior Medical Reviewer is responsible for conducting comprehensive medical reviews of clinical trial data across various therapy areas within the drug development portfolio. This role ensures the highest quality and consistency of medical data, with a strong emphasis on patient safety, protocol adherence, and compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations, and Standard Operating Procedures (SOPs). Key responsibilities include collaborating closely with study team members"”such as Data Managers, Trial Managers, and Medical Specialists"”throughout the trial process, providing timely updates on the status of medical reviews, and escalating any issues to maintain trial integrity and compliance. Responsible for contribution to or participation in trial planning activities related to medical review. Perform the quality check measure for the medical review. Responsible for clarifying and if possible, resolving issues of medical concern and inconsistencies in clinical trial data with staff at investigational sites. Responsible for presenting findings of Medical Review to relevant Medical Specialists to enable decision-making. Responsible for documenting medical reviews in the sponsor TMF. Ensure close collaboration with relevant study group members, especially the Data Manager, Trial Manager(s), and Medical Specialist during trial conduct. Provide training on the project and process to the new team members. Review and provide inputs to MMP as well as Medical Monitoring, Displays or other data listing required to perform Medical review. The input should ensure unambiguous monitoring requirements as well as medical monitoring displays and data listing to enable efficient medical review. Qualifications: A graduate degree in Medicine or a related field is required (MBBS & MD in Pharmacology preferred; MBBS & MD in other clinical or paraclinical areas with relevant experience in clinical patient management or clinical research will also be considered). Preferably 3-5 years of relevant experience in Clinical Drug Development (Medical Data Review, Medical Monitoring, Investigator, Safety Surveillance, Scientific Clinical Drug Development etc). 1-2 years of project management experience is essential. Solid understanding of ICH (International Council for Harmonisation) guidelines and GCP (Good Clinical Practice) principles. Proficient in computer applications, including MS Office, MS Project, and PowerPoint. Strong grasp of medical terminology and clinical trial processes. Demonstrated analytical skills with a results-oriented approach. Exceptional proficiency in written and spoken English.

Position Overview: We are seeking a highly experienced and visionary Medical Director to lead and oversee all medical and clinical initiatives within the organization. This role is pivotal in ensuring the medical and scientific integrity of our programs, providing strategic direction, and driving excellence across research, clinical operations, and stakeholder engagement. The ideal candidate will bring deep clinical expertise, strong leadership capabilities, and a passion for advancing healthcare outcomes through evidence-based practices and innovative solutions. Key Responsibilities: Provide strategic medical leadership across all research, clinical, and operational activities. Oversee the design, execution, and evaluation of clinical trials and research studies. Ensure compliance with all regulatory requirements, ethical standards, and Good Clinical Practice (GCP) guidelines. Serve as the primary medical representative in internal leadership discussions and external engagements with regulators, academic institutions, partners, and key opinion leaders (KOLs). Review, interpret, and communicate clinical and scientific data to support organizational goals and initiatives. Guide the development of medical content including clinical study protocols, scientific publications, regulatory documents, and strategic medical plans. Collaborate closely with cross-functional teams including R&D, Regulatory Affairs, Pharmacovigilance, and Commercial functions to align medical strategy with organizational objectives. Lead and mentor a multidisciplinary team of medical professionals and clinical staff. Support the development of risk management plans, safety monitoring, and adverse event reporting systems. Contribute to strategic planning and organizational growth from a medical perspective. Required Qualifications & Experience: MBBS/MD or equivalent medical degree (Postgraduate specialization in relevant field preferred) Minimum 1015 years of progressive experience in clinical research, medical affairs, or healthcare leadership roles Demonstrated experience in clinical development, regulatory affairs, and medical governance In-depth understanding of medical ethics, patient safety, and quality standards in clinical settings Proven track record of cross-functional leadership and stakeholder engagement Excellent analytical, communication, and decision-making skills Experience in interacting with regulatory authorities and health policy bodies is highly desirable

The Medical Monitor will serve as the primary medical expert responsible for the safety and scientific integrity of clinical trials. This role provides medical oversight to ensure patient safety, proper conduct of trials

Hi We are looking forward to hire Medical Monitor for our Client. Please go through the JD and Apply Responsibilities: Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings Qualification: MBBS/ MD qualification Eligibility: 3 year+ of clinical trial experience Familiar with clinical trials operations Good English communication skills Proficiency in using Microsoft office To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 362 b) For Position in Pune Search : Job Code # 363 c) For Position in Bangalore Search : Job Code # 364

Urgent Hiring for NO-1 IT MNC for Medical Monitor ( SR Manager ) Location - Mumbai Salary Up-to - 30 LPA ONLY MBBS / MD with 3 + Yrs exp required In Clinical Trial Operations ,Review AE/SAEs protocols etc. Call @ WhatsApp- Vishakha - 8287990567

Hi We are looking forward to hire Medical Monitor for our Client. Please go through the JD and Apply Responsibilities: Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings Qualification: MBBS/ MD qualification Eligibility: 3 year+ of clinical trial experience Familiar with clinical trials operations Good English communication skills Proficiency in using Microsoft office To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 362 b) For Position in Pune Search : Job Code # 363 c) For Position in Bangalore Search : Job Code # 364

Skill required: Clinical Data Services - Medical Monitoring Designation: Clinical Data Svs Associate Qualifications: BTech/Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.Provides medical expertise for trial oversight and safety concerns. This includes creation, review and validation of protocol requirement specifications as per the applicable SOP. What are we looking for? Ability to work well in a team Adaptable and flexible Strong analytical skills Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualifications BTech,Bachelor of Pharmacy,Master of Pharmacy

Role & responsibilities Associate Research Physician in clinical trial related projects covers various therapeutic areas, medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation and in accordance with applicable regulatory and SOP requirements. Support in the preparation and review of protocol related appendices like Investigators Brochure, Informed Consent Document, Investigators Undertaking, and any other documents related to protocol and CSR. Review of the MedDRA and WHO Drug Insight coding as and when required for the projects. Support the Senior Research Physician in generating SAE narratives and performing quality review and analysis of similar events. Communication of the SAE to all stakeholders as per the format and timelines indicated in the guidelines and internal SOP and keep a track of the same when required for clinical trials. Take a lead role in drafting the Integrated Summary of Safety and Efficacy for all clinical trial projects where in he/she is designated the responsibility. Review of protocol and protocol synopsis for BA/BE and phase studies in collaboration with clinicians, bioanalytical personnel, biostatisticians, regulatory affairs personnel, and medical monitor. Preparation of Medical Monitoring Plan (MMP) and Risk Evaluation and Mitigation Strategy (REMS), if applicable. Preparation of SFQs (Site Feasibility Questionnaires) and summary for patient-based studies. Training the required study team members and addressing protocol related queries in a timely manner. Provide input regarding deliverables with accuracy timelines and processes and support completion of quality regulatory documents. Managing documents with multiple review cycles and deadlines

Hi We are looking forward to hire Medical Monitor for our Client. Please go through the JD and Apply Responsibilities: Review protocol and provide suggestions Respond to queries/ clarifications from EC/ IRBs Answer medical questions from sites or project team Respond to queries from sites with regard to protocol Attend drug safety meetings/ external meetings Patient eligibility review Review AE/ SAEs Protocol training to site staff, CRAs etc Attend, participate/ present in investigator meetings Qualification: MBBS/ MD qualification Eligibility: 3 year+ of clinical trial experience Familiar with clinical trials operations Good English communication skills Proficiency in using Microsoft office To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 362 b) For Position in Pune Search : Job Code # 363 c) For Position in Bangalore Search : Job Code # 364