1188 Clinical Research Jobs - Page 23

We are seeking a Consultant Pulmonary to join our healthcare team in India. The ideal candidate will have 0-5 years of experience in pulmonary medicine and will be responsible for diagnosing and treating patients with respiratory conditions, ensuring high-quality patient care. Responsibilities Conduct thorough assessments of patients with respiratory issues. Develop and implement treatment plans for pulmonary diseases. Perform diagnostic procedures such as bronchoscopy and pulmonary function tests. Collaborate with other healthcare professionals to ensure comprehensive patient care. Educate patients and their families about respiratory conditions and treatment options. Stay updated on the latest research and advancements in pulmonary medicine. Skills and Qualifications MBBS degree from a recognized institution. MD in Pulmonary Medicine or equivalent. Strong understanding of respiratory diseases and treatments. Experience with diagnostic procedures related to pulmonary care. Excellent communication and interpersonal skills. Ability to work collaboratively in a multidisciplinary team.

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage Should have good communication Skills

We are seeking a skilled and dedicated Consultant Urology to join our healthcare team in India. The ideal candidate will have a strong background in urological care, with the ability to diagnose and treat a wide range of urological conditions. This role requires a passion for patient care and a commitment to excellence in clinical practice. Responsibilities Diagnose and treat patients with urological conditions and diseases. Perform urological surgeries and procedures as required. Conduct patient consultations and follow-up visits. Collaborate with a multidisciplinary team to ensure comprehensive care. Maintain accurate patient records and documentation. Participate in research and clinical trials as applicable. Educate patients and their families on urological health and treatment options. Skills and Qualifications MBBS degree from a recognized institution. Postgraduate qualification in Urology (DNB, MS, or equivalent). 1-5 years of experience in Urology, preferably in a clinical setting. Strong clinical assessment and diagnostic skills. Proficiency in urological procedures and surgeries. Excellent communication and interpersonal skills. Ability to work collaboratively in a team environment. Familiarity with electronic health records and patient management systems.

We are seeking a Consultant Gastroenterologist to join our medical team in India. The ideal candidate will have 0-5 years of experience in the field of gastroenterology, providing expert care for patients with various gastrointestinal disorders. The consultant will be responsible for evaluating, diagnosing, and treating patients while collaborating with other medical professionals to ensure comprehensive patient care. Responsibilities Conduct thorough patient evaluations and assessments for gastrointestinal disorders. Develop and implement treatment plans for patients with various gastroenterological conditions. Perform diagnostic procedures such as endoscopies and colonoscopies as required. Collaborate with other healthcare professionals to provide comprehensive care to patients. Stay updated with the latest advancements in gastroenterology and participate in continuous education. Educate patients and their families on diet, lifestyle changes, and treatment options. Skills and Qualifications MBBS degree from a recognized institution. Postgraduate qualification in Gastroenterology (DM/DNB) or equivalent. Strong clinical skills and knowledge of gastroenterological diseases. Proficiency in performing endoscopic procedures and interpreting diagnostic tests. Excellent communication skills to interact with patients and healthcare teams. Ability to work in a fast-paced environment and manage multiple patient cases effectively.

We are seeking a Consultant Nephrologist to join our esteemed healthcare team in India. The ideal candidate will be responsible for diagnosing and treating patients with kidney-related issues, providing comprehensive care, and contributing to the overall health and well-being of our patients. This role is suitable for candidates with 0-3 years of experience in the field. Responsibilities Conducting consultations with patients suffering from kidney-related diseases. Diagnosing and treating various nephrological conditions. Performing kidney biopsies and interpreting results. Collaborating with healthcare professionals to develop patient care plans. Educating patients and families about kidney health and management options. Participating in clinical research and trials related to nephrology. Staying updated on the latest advancements and best practices in nephrology. Skills and Qualifications MD or DNB in Nephrology or equivalent qualification. Strong understanding of kidney diseases and treatments. Excellent diagnostic skills and attention to detail. Effective communication and interpersonal skills. Ability to work collaboratively in a multidisciplinary team. Proficiency in performing nephrology procedures such as dialysis and biopsies. Commitment to continuing education and professional development.

We are seeking a skilled Consultant Neurosurgeon with 1-5 years of experience to join our medical team in India. The ideal candidate will be proficient in performing a range of neurosurgical procedures and possess a strong commitment to patient care. Responsibilities Conducting thorough assessments of patients with neurological disorders. Performing complex neurosurgical procedures with precision and care. Collaborating with multidisciplinary teams to develop comprehensive treatment plans. Providing post-operative care and follow-up for patients. Staying updated with the latest advancements in neurosurgery and medical technologies. Skills and Qualifications MBBS degree from a recognized medical college. MS in General Surgery or equivalent. MCh in Neurosurgery or equivalent qualification. Strong manual dexterity and surgical skills. Excellent communication and interpersonal skills. Ability to work under pressure and make quick decisions in critical situations.

Review and execute physician’s prescriptions checking their appropriateness and legality. Maintain full control over delivering, stocking and labeling medicine and other products and monitor their condition to prevent expiring or deterioration. Required Candidate profile Thorough understanding of dosage administration and measurement, chemical compounds, medical brands etc. Excellent communication skills with a customer oriented approach. Integrity and compassion. Perks and benefits Health insurance Retirement plans Paid time off

Manager - Business Development (Clinical Research)Role and Responsibilities: The Lead - Strategic Business Development will play a crucial role in maintaining strong client relationships, handling clients, and acquiring new clients for our Business Development process They will be responsible for positioning MakroCare's specialized services with strategic planning and implementation for medical devices and diagnostics companies in Europe and the USA Additionally, the role involves developing and implementing business development strategies, maintaining international contacts, achieving sales targets, and working with the marketing and pre-sales teams for lead generation Candidate Qualifications: Bachelor's Degree in any Life Science with an MBA/PGDM certification Minimum of 8 - 12 years of experience in the BA BE/CRO industry as a Business Development Proven success and experience in regulatory projects within the Biotech/Life sciences/pharmaceutical environment Experience in international pharmaceutical projects with excellent communication skills Cooperative and assertive working style with the ability to understand and explain complex relationships Basic knowledge of data fields related to pharmaceutical products Required Skills: Business Development Strategy & Services Client Handling New Client Acquisition HealthCare, Medical Devices, Regulatory Affairs & Clinical Research

Communicate with stakeholders to ensure mutual understanding of requirements and functional specifications Review business processes involving assigned business applications and develop optimization strategies, including gathering critical information from meetings with various stakeholders and producing useful reports Evaluate needs and determination of feasibility based on business application capabilities and process improvement standards Document and effectively communicate your efforts, insights, and recommendations, including conducting meetings and presentations to share ideas and findings Ensure assigned business applications and processes meet business needs and requirements through user acceptance testing Research and propose efficient and economical ways to improve processes and optimize efficiencies within the assigned business applications Develop relationships throughout the company and its affiliates Assist with creation of and update training documents related to assigned business applications Develop skills in multiple technical environments and grasp a variety of business processes Resolve support issues related to assigned business applications Supports adoption efforts and usage optimization related to assigned business applications Assist with development of communications (both in written and in presentation formats) that convey ideas and recommendations in a clear and convincing way related to assigned business applications Build vendor partnerships for assigned applications Provides coaching and training as needed for new or junior team members Assist with release management for assigned applications May serve as technical owner of assigned applications May participate in validation activities as needed Other duties as assigned Overview Job Posting Title India Remote/Ahmedabad/Bengaluru/New Delhi Emmes Group: Building a better future for us all Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience We believe the work we do will have a direct impact on patients lives and act accordingly We strive to build a collaborative culture at the intersection of being a performance and people driven company We re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company If you share our motivations and passion in research, come join us! Primary Purpose The Application Analyst supports assigned Level 1 or 2 business applications and works with staff to collect information about current business processes to determine impact to the business application Application Analysts may serve as backup or trainee on Level 3 business applications The Application Analyst advises management on best outcomes and will support colleagues from across the company to resolve business process and application issues and put appropriate solutions in place Application Analysts also provide support within initiatives related to assigned business applications Responsibilities Communicate with stakeholders to ensure mutual understanding of requirements and functional specifications Review business processes involving assigned business applications and develop optimization strategies, including gathering critical information from meetings with various stakeholders and producing useful reports Evaluate needs and determination of feasibility based on business application capabilities and process improvement standards Document and effectively communicate your efforts, insights, and recommendations, including conducting meetings and presentations to share ideas and findings Ensure assigned business applications and processes meet business needs and requirements through user acceptance testing Research and propose efficient and economical ways to improve processes and optimize efficiencies within the assigned business applications Develop relationships throughout the company and its affiliates Assist with creation of and update training documents related to assigned business applications Develop skills in multiple technical environments and grasp a variety of business processes Resolve support issues related to assigned business applications Supports adoption efforts and usage optimization related to assigned business applications Assist with development of communications (both in written and in presentation formats) that convey ideas and recommendations in a clear and convincing way related to assigned business applications Build vendor partnerships for assigned applications Provides coaching and training as needed for new or junior team members Assist with release management for assigned applications May serve as technical owner of assigned applications May participate in validation activities as needed Other duties as assigned Qualifications Bachelor s degree in Business or related field with 2+ years of analytical experience Experience in configuring and resolving issues in multiple Veeva Vaults required Exceptional analytical and conceptual thinking skills Ability to influence stakeholders and work closely with them to determine acceptable solutions Excellent communication and documentation skills, including technical writing Experience creating detailed assessments and giving presentations Excellent planning, organization, and time management skills Experience leading and supporting successful projects Experience with strategic business process modeling and traceability CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes #LI-Remote

Leads project-specific certification activities at the direction of the Manager, OCMPG and Ophthalmic Certification Project Managers Performs certification data entry and works in the certification database at the direction of the Manager, OCMPG and Ophthalmic Certification Project Managers Assists with providing support in tracking, compiling, and submitting project deadlines and deliverables Assists with the collection of electronic and paper-based project files and archives Assists with the review of study related documents, certifications and data to ensure quality and accuracy Supports the coordinating of conference calls and meetings Edits, formats, tracks and distributes technical and non-technical reports Attends and participates in department team meetings Performs other duties as assigned Overview Ophthalmic Certification Project Associate India - Bangalore Emmes Group: Building a better future for us all Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience We believe the work we do will have a direct impact on patients lives and act accordingly We stive to build a collaborative culture at the intersection of being a performance and people driven company We re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company If you share our motivations and passion in research, come join us! This requirement is for our OptymEdge division OptymEdge sets the gold standard for training and certification in ophthalmic clinical trials and brings experience and expertise from having the largest and longest-standing certification organization in the industry Pioneering visual acuity certification from conception, we have developed proven solutions for training and certification of Visual Function Examiners and Visual Function Rooms, and partner with study teams to provide visual function certification that ensures a high level of quality and consistency for ophthalmic clinical trial data OptymEdge has certified over 2000 sites worldwide since 1995, working on Phase I through post-marketing trials in clinical Ophthalmology, Optometry, and other therapeutic areas Primary Purpose The Ophthalmic Certification Project Associate (OCPA) is critical to the successful conduct of ophthalmic certifications in Biopharmaceutical-sponsored clinical trials The OCPA supports the Manager, Ophthalmic Certification Project Management Group (OCMPG) and Ophthalmic Certification Project Managers by providing logistical support for electronic document filing and archiving, reporting requirements and other duties required by the statement of work The OCPA will be site-facing through the life cycle of the study, and contributes to team and financial efficiency, work product quality, and client satisfaction through strong relationship management Responsibilities Leads project-specific certification activities at the direction of the Manager, OCMPG and Ophthalmic Certification Project Managers Performs certification data entry and works in the certification database at the direction of the Manager, OCMPG and Ophthalmic Certification Project Managers Assists with providing support in tracking, compiling, and submitting project deadlines and deliverables Assists with the collection of electronic and paper-based project files and archives Assists with the review of study related documents, certifications and data to ensure quality and accuracy Supports the coordinating of conference calls and meetings Edits, formats, tracks and distributes technical and non-technical reports Attends and participates in department team meetings Performs other duties as assigned Qualifications Bachelor s degree preferred or equivalent experience will be considered 2 years demonstrating related experience Demonstrated experience with MS Office Suite, particularly MS Word Time management and decision-making skills Attention to detail and the ability to address several assignments simultaneously Excellent oral and written communication skills Some knowledge of clinical trials in ophthalmology preferred CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes

Data for AI: Design and implement data pipelines specifically tailored for AI training and model development. Partner with AI data scientists and engineers to understand their data needs and ensure efficient data access. Implement data pre-processing and feature engineering techniques for optimal model performance. AWS expertise: Design,develop, and maintain data infrastructure on the AWS cloud platform, leveraging services like S3,Redshift, Glue, Lambda, and Kinesis. Build and maintain data lakes and warehouses optimized for AI workloads. Implement automated data transformations,cleansing, and validation processes to ensure data quality. Coding proficiency: Write code using Python,SQL, and other relevant programming languages, with a focus on libraries and frameworks commonly used in AI (e.g., TensorFlow, PyTorch). Automation and monitoring: Automate data pipelines using CI/CD tools and related techniques. Monitor and troubleshoot data pipelines for performance, reliability,and data quality issues. Overview The Emmes Company, LLC ( Emmes ) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass. Our Character Achieves Results culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research. If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee from entry level through top executive to contribute to our clients success by sharing ideas openly and honestly. Primary Purpose Building and maintaining our data infrastructure on the AWS cloud platform, with a specific focus on supporting AI model training, development, and deployment. This includes designing, developing, and implementing data pipelines, ensuring the secure and efficient flow of data for our AI models. Responsibilities Data for AI: Design and implement data pipelines specifically tailored for AI training and model development. Partner with AI data scientists and engineers to understand their data needs and ensure efficient data access. Implement data pre-processing and feature engineering techniques for optimal model performance. AWS expertise: Design,develop, and maintain data infrastructure on the AWS cloud platform, leveraging services like S3,Redshift, Glue, Lambda, and Kinesis. Build and maintain data lakes and warehouses optimized for AI workloads. Implement automated data transformations,cleansing, and validation processes to ensure data quality. Coding proficiency: Write code using Python,SQL, and other relevant programming languages, with a focus on libraries and frameworks commonly used in AI (e.g., TensorFlow, PyTorch). Automation and monitoring: Automate data pipelines using CI/CD tools and related techniques. Monitor and troubleshoot data pipelines for performance, reliability,and data quality issues. Qualifications 5 to 8 years of experience as a Data Engineer or similar role,with a demonstrated experience in supporting data pipelines for AI applications and their data requirements. Proven experience with AWS services,including S3, Redshift, Glue, Lambda, and Kinesis. Strong experience with Python and SQL. Strong understanding of AI libraries and frameworks. Experience with data warehousing and data modeling concepts. Excellent problem-solving and analytical skills. Ability to work independently and as part of a collaborative team. Strong communication and collaboration skills. CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - The Emmes Company, LLC

Overview Job Posting Title India Remote/Ahmedabad/Bengaluru/New Delhi Emmes Group: Building a better future for us all Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience We believe the work we do will have a direct impact on patients lives and act accordingly We strive to build a collaborative culture at the intersection of being a performance and people driven company We re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company If you share our motivations and passion in research, come join us! Primary Purpose Responsibilities Qualifications CONNECT WITH US! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - Emmes #LI-Remote

About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers. About the role We have a opportunity for a Medical Device Assessor/ Auditor to join our India Team. The successful candidate will be responsible for, planning and conducting audits/ assessments, in accordance with ISO 13485, EU MDR, and MDSAP standards and related (eg IMDR). Key Accountabilities: Technical Compliances, Accreditation Requirements and collaborating with a Team of Auditors/ Assessors. Conduct audits (either desk-based or on client s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Conduct Technical File reviews specific for products being authorized. Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business. Complete specific projects in relation to medical device procedures, processes, systems and documentation. If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements. Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards. To be considered for this role, you ll require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs: work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies. work in the application of device technology and its use in health care services and with patients. testing devices for compliance with the relevant national or international standards. conducting performance testing, evaluation studies or clinical trials of devices. 5 + years relevant professional experience in quality management is essential. In addition to the above you ll also need to demonstrate the following. An excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application Knowledge of MDR 2017/745, MDSAP, IMDR Work experience in positions with significant QA, Regulatory or management systems responsibility Experience with Harmonized medical device standards and for active non active devices. Experience with Risk Management EN ISO 14971 Experience auditing against recognized standards Experience of working under own initiative and in planning and prioritizing workloads Solid knowledge of non-active devices Solid knowledge of sterilization processes The following attributes are essential: Work actively with a Team of Assessors/ Auditors. Experience of reviewing audit packs Review of technical documentation Registered IRCA lead auditor, or equivalent registration under other recognized body What we offer Flexible work arrangements for better work-life balance Generous Paid Leaves (Annual, Sick, Compassionate, Local Public, Marriage, Maternity, Paternity, Medical leave) Medical benefits ( Insurance and Annual Health Check-up) Pension and Insurance Policies (Group Term Life Insurance, Group Personal Accident Insurance, Travel Insurance) Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme) Additional Benefits (Long Service Awards, Mobile Phone Reimbursement) Company bonus/Profit share. *Benefits may vary based on position, tenure/contract/grade level* About you University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Computer Software Technology, Engineering, Nursing, Quality Management. Qualified MDR Assessor from a reputed EU Notified Body, desirable. Experience with scientific literature searches or peer review in the medical context. Fluent in written and spoken English. Experience working with Various Digital Tools. Excellent organizational and professional communication skills.

Job Overview: Provide basic and some comprehensive data management expertise to the eCOA Data Management (DM) team to deliver efficient, quality data management products that meet customer needs. May also undertake eCOA Data Management activities under the supervision of the Data Team Lead (DTL)/ Sr DTL, or Functional Manager. Essential Functions: - Undertake eCOA Data Management activities for assigned studies, with/without supervision. - May serve in the role of back-up to a DTL. - Perform testing of programming and data transfers. - Understand and comply with core operating procedures and working instructions. - Meet objectives as assigned and develop and maintain good communications and working relationships within eCOA DM team. - Database Design and Maintenance: Create and maintain clinical databases to ensure they are efficient and meet the needs of the clinical trials. - Data Querying and Reporting: Manage queries and generate reports for analysis. - Data Validation: Analyze and resolve discrepancies from Recon/CTMS inquiries. - Study Close-out: Execute end-to-end study close-out activities, include Archival. - Identify opportunities to automate and improve data collection and management processes. Qualifications: - Bachelor s degree in pharmacy or equivalent preferred. - 3-6 years of direct data management experience, preferably a minimum of 1 year as a CDM project lead. - Good to have experience in electronic Clinical Outcome Assessment (eCOA) or Decentralized Clinical Trials (DCT). - Advanced proficiency in English, both spoken and written. - Advanced skills in computer applications like Microsoft Excel, Word, Outlook, etc. - Advanced understanding of the drug development lifecycle and overall clinical research process. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Identify new sites, PIs and Assists in evaluating new protocols for feasibility at the site. To coordinate with Principal Investigator, Institutional Review Board/ Institutional Ethics Committee, Sponsor/CRO & Team for conduct of the clinical research/trials. Reviewing the protocol/synopsis and other materials, such as NDA, feasibility questionnaire and Approached to PIs as per study indication for further process discussion. Assessing the ability to meet the study timelines in light of other site commitments and overall feasibility Looking at subject eligibility requirements and determining if those subjects would be available in the practice. Assessing the resources necessary to do the study, including people, physical space, etc Collecting curriculum Vitae, MRC, and GCP Certificate of Principal Investigator, sub- Investigator and other study professionals, and send along with completed Site feasibility questionnaire. Assessing for Site Selection Visit (SSV) & Site Initiation Visit (SIV). To conduct the clinical trial according to ICH-GCP guidelines, New drugs and Clinical trials rules 2019, and other applicable regulatory guidelines. To systematize processes in order to attend high level of standards during research process. Preparing documents for submission to the Institutional Review Board (IRB)/ IEC Attending the Investigator meeting, as appropriate, and train staff about their duties related to the ongoing clinical trial. To obtain and document the Informed Consent form which should comply with the applicable regulatory requirements and adherence to GCP and to the ethical principles that have their origin in the declaration of Helsinki. Presenting the informed consent form to potential subject, discussing the consent and the study with them and answering questions. Obtaining subject s signatures on the informed consent forms, and ensuring that all necessary signature and dates are on the ICF. Documenting, distributing and filing assigned informed consent forms appropriately. Ensuring that all amended consent forms are appropriately implemented and signed. To ensure that neither the investigator nor the trial staff, should coerce or unduly influence a subject to participate or to continue participate in the trial. To ensure that the rights and we'll-being of the subjects are protected. To provide patient Information sheet to the subject. Contacting and screening potential subjects for the study. Recruiting Subjects, Scheduling Subject and Sponsor Visits. Preparing for each subject visit to ensure that all appropriate study procedures are done. Assisting the Investigator with study subject visits. Ensuring that All necessary data are gathered and recorded in the appropriate source documents (ie, Patient charts) and the case reports forms. Reviewing case report forms entries for completeness, correctness and logical sense in addition, review the source documents and case report orms for adverse events that may have been missed. Working with sponsor monitors (CRAs) during monitoring visits. Making corrections to the case report forms, if appropriate and resolving data queries. Managing laboratory procedures (drawing samples, Processing, packaging and shipping). Preparing Invoices and managing payments to study subjects, if appropriate. Preparing Invoices and managing payments to study subjects, if appropriate.

The core responsibility for this position is as a member of Novotech s Data Management group. The Senior Clinical Data Manager s (SCDM s) role is to control all aspects of data management and to ensure compliance with Good Clinical Data Management Practices (GCDMP). As an experienced CDM, the SCDM provides mentorship to junior staff and can also provide support to the project manager. Expectation of being a leader within the department by leading process improvements, new initiatives as we'll as training for junior colleagues. Minimum Qualifications Experience: Graduate in a clinical or life sciences related field. At least eight to ten years experience in a similar role working in the research, pharmaceutical industry or a related field. Responsibilities: Member of the project team reporting to the Project Manager for integrated projects, the Senior Clinical Data Manager is responsible for planning, conducting, and managing all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements, and SOPs. Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required. If full service, then collaborate with PM to ensure appropriate mitigation and contingencies are initiated. May function as Project Manager for stand-alone data management projects. Participates in project team meetings as required. Input into the preparation of RFPs in liaison with BD and the clinical team. Liaison with the project team and client for preparing and maintaining Data Management Plans. Responsible for all aspects of data management including: Design and review of database structure, validation rules and consistency checks. Operation of Clinical Data Management Systems. All data cleaning/validation tasks. Development of all key Data Management Documents. Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stakeholders. Liaison with external service providers on Data Management projects as appropriate. Assist in the development of protocols as required. Supervision and training support for junior and contract Data Management staff as required. Adherence to company Quality Policy and procedures applicable to fulfilling job responsibilities. Active contribution in Data Management process improvement including identification of and participation in process improvement initiatives. Perform accurate study financial projections and maintain monthly project financials. Ensure changes in scope are identified and actioned accordingly. Provide expert assistance and input into internal cross-functional projects including clinical research and regulatory affairs, as assigned. Project management of internal IT-based company projects as assigned (eg, intranet development, client database applications etc). Active contribution to company business development initiatives, including involvement in the implementation of data management plans for business development in the company in general. Participation in industry fora (conferences, professional association committee work, etc) as a means of professional development as we'll as promotion of Novotech s image in industry

Education: B.SC/M.SC/B.Pharm/M.Pharm Job Description: Multiple mailboxes handling, fluent in English (written/verbal communications), proactive for communications, Co-ordinating with clients as first contact point for routine communications, support during audits/inspections Basic knowledge of pharmacovigilance we'll versed with MS outlook, Powerpoint, Excel. COMPETENCIES Accountability Communication Work Ethic Leadership Presentation / Communication skills Organizational Culture fit

Conduct testing activities and provide comprehensive testing expertise to produce efficient, quality database that meets customer requirements. Provide support in creation of Test Plan and handling of validation projects. May act as Validation Team Lead. May undertake selected team leadership activities under supervision of Manager. Independently conduct testing activities to validate Edit Checks, other components, SAS listings, Transfer program and custom reports in platforms like Inform, RAVE, OCRDC, Oracle Clinical. Should have high expertise in Testing activities and excellent knowledge of Database. Advanced understanding of database structures. Perform eCRF and Time Events QC as per QC checklist. Provide support to Validation Team Leads as required and contribute towards creation of test cases, documentation and communication with internal customers. Support Validation Team Lead in overall management of validation projects. May take complete responsibility for delivery of a validation project. Understand all the documentation requirements with regards to validation very we'll and update all relevant documents in a timely manner. May monitor documentation compliance for junior team members. Ensure validation processes and best practices are being followe'd strictly by self and team. May assist with creation/review of now processes/best practices. Communicate status of the projects to the Validation team Lead/Manager/ Data Team Lead/Programmer. Support Validation Team Lead/Manager with daily tasks allocation for validation projects. Escalate problems to the attention of the Validation team Lead or Manager. Conduct Quality Reviews of Testing projects on an ongoing basis as applicable. Conduct Knowledge Sharing and Lessons Learnt sessions regularly. Review and update relevant documents accurately and completely on time. May document all testing documentation in eDMSF. May serve as Subject Matter Expert (SME). Mentor Associate Validation Analysts/Validation Analysts in all validation activities. May provide metrics support to Validation Team Lead or Manager. Identify areas for process improvements continuously. Actively take part and contribute towards process improvement initiatives s assigned besides providing suggestions/ideas for continuous improvement of the process. Understand and comply with core Operating Procedures and Work Instructions (including Best Practice and Guidance documents). Meet project objectives as assigned by Validation Team Lead or Manager. Develop and maintain good communication and working relationships with validation teams across sites. All responsibilities are essential job functions unless noted as nonessential (N). Qualifications Bachelors Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req 2- 4 years of relevant clinical DB Testing experience in CDMS Platforms and total exp being 4+ yrs Req

[{"Salary":"20 - 25 K" , "Remote_Job":false , "Posting_Title":"HR Manager" , "Is_Locked":false , "City":"Coimbatore South" , "Industry":"Pharma / Biotech / Clinical Research","Job_Description":" Post job openings on company portals and external job boards Arrange and coordinate interviews for various roles Oversee onboarding and induction process for new employees Manage all HR operations for LinkBridge divisions Hire, manage, and nurture interns (both paid and unpaid) Organize and conduct training for new joiners Manage exit interviews and offboarding formalities Prepare, review, and manage employee agreements and documentation Requirements \u200b Must be based in Coimbatore Should own a two-wheeler for local travel Female candidates preferred Married candidates preferred Strong communication and organizational skills Experience in HR or administration will be an added advantage \u200b Benefits Salary: \u20b925,000 per month ESI and PF benefits as per company policy Opportunity to work in a dynamic and supportive environment Exposure to multiple divisions and HR functions Professional growth and career advancement ","Work_Experience":"0-1 year","Job_Type":"Full time","Job_Opening_Name":"HR Manager","State":"Tamil Nadu" , "Currency":"INR" , "Country":"India" , "Zip_Code":"641001" , "id":"63864000002271284" , "Publish":true , "Date_Opened":"2025-06-02" , "Keep_on_Career_Site":false}]

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as an Assistant Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables. Reporting study needs and issues Supporting overall project start-up, execution and close out activities Supporting project finance-related activities such as: Assistance with documentation / database updates due to project scope changes Follow-up related to invoice reconciliations. Preparation of project reports in support of project forecasting activities Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by: Monitoring internal data flow to ensure completion of tasks within agreed upon timeframes Responding to inquiries in a professional, courteous, and timely manner Communicating with clients regarding project status Verifying protocol imaging requirements are met and queries appropriately identified Serving as acting Project Manager in the absence of the assigned Project Manager Creating, reviewing, and distributing (internally and/or externally) project report(s) Ensures the development and adherence to project timelines by: Following up on outstanding items including missing data, incomplete paperwork, queries, etc. Assisting in tracking and resolving of client issues Serving as additional point of contact to client, sites, sponsors, etc. Supporting Logistics with the distribution, management and tracking of site-facing materials Keeping clinical project manager(s) (CPM) and supervisor advised of current issues Maintains Quality Service and Departmental Standards by Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Executing technical and clinical functions as required by the study protocol in accordance with Clario s GCP s, ICH and FDA Guidelines. Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives. What we look for Bachelor s Degree preferred 1 + years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred Strong experience with and knowledge of the Microsoft Office suite of software productivity tools Healthcare, medical experience, and/or clinical research, preferred Strong organizational, interpersonal, time management, and prioritization skills Excellent interpersonal, verbal and written communication skills, including ability to communicate effectively in English Detail oriented, meticulous, and responsive to inquiries and requests Ability to work independently, and to collaborate in a team setting Ability to deal with uncertainty, and adapt to changing priorities Pragmatic, proactive and goal oriented Ability to project and maintain a professional and positive attitude. .

Are you looking for a meaningful and fulfilling career in Project Management within the Clinical Research industry? Join Clarios Medical Imaging team in Bengaluru, India, and be part of a legacy with over 30 years of expertise. We specialize in providing seamless, secure, and compliant medical imaging solutions that enhance clinical trials. At Clario, we have ambitious goals and a clear vision for the future. This is your chance to be part of our journey as an Assistant Clinical Project Manager. What we offer Competitive compensation Attractive benefits (security, flexibility, support and well-being) Engaging employee programs Technology for hybrid working and great onsite facilities What youll be doing Assists Clinical Project Managers with project administration by: Developing project related documents Reviewing and editing project presentations Participating in project meetings, conference calls, and training calls Reading and understanding project protocol documents Acting as a liaison with cross-functional team members to ensure timely completion of all study deliverables. Reporting study needs and issues Supporting overall project start-up, execution and close out activities Supporting project finance-related activities such as: Assistance with documentation / database updates due to project scope changes Follow-up related to invoice reconciliations. Preparation of project reports in support of project forecasting activities Assists Clinical Project Managers in maintaining, reviewing, and communicating project progress by: Monitoring internal data flow to ensure completion of tasks within agreed upon timeframes Responding to inquiries in a professional, courteous, and timely manner Communicating with clients regarding project status Verifying protocol imaging requirements are met and queries appropriately identified Serving as acting Project Manager in the absence of the assigned Project Manager Creating, reviewing, and distributing (internally and/or externally) project report(s) Ensures the development and adherence to project timelines by: Following up on outstanding items including missing data, incomplete paperwork, queries, etc. Assisting in tracking and resolving of client issues Serving as additional point of contact to client, sites, sponsors, etc. Supporting Logistics with the distribution, management and tracking of site-facing materials Keeping clinical project manager(s) (CPM) and supervisor advised of current issues Maintains Quality Service and Departmental Standards by Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs) Executing technical and clinical functions as required by the study protocol in accordance with Clario s GCP s, ICH and FDA Guidelines. Reviewing and providing recommendations to management on operational procedures, and by participating in process improvement initiatives. What we look for Bachelor s Degree preferred 1 + years of experience working in pharmaceutical drug development, clinical trials, and/or clinical research preferred Strong experience with and knowledge of the Microsoft Office suite of software productivity tools Healthcare, medical experience, and/or clinical research, preferred Strong organizational, interpersonal, time management, and prioritization skills Excellent interpersonal, verbal and written communication skills, including ability to communicate effectively in English Detail oriented, meticulous, and responsive to inquiries and requests Ability to work independently, and to collaborate in a team setting Ability to deal with uncertainty, and adapt to changing priorities Pragmatic, proactive and goal oriented Ability to project and maintain a professional and positive attitude. .

Qualification MBBS / BDS with three years post-qualification experience OR MBBS / BDS + Post Graduate Degree (MD/MDS/MPH) or any equivalent degree (MSc Public Health / Clinical Research / Pharmaceutical Medicine, etc.) including integrated PG degrees OR MBBS/ BDS with PhD (relevant subject) Experience Desirable: DGO/DNB/MD/MS in Obstetrics & Gynaecology with interest in research evident from publications. OR Clinical research/ Clinical trial experience, or experience of handling R & D projects in a reputed institute/ pharmaceutical company/ CRO

Brief Description: The core responsibility for this position is as a member of Novotech s Data Management group. The Senior Clinical Data Manager s (SCDM s) role is to control all aspects of data management and to ensure compliance with Good Clinical Data Management Practices (GCDMP). As an experienced CDM, the SCDM provides mentorship to junior staff and can also provide support to the project manager. Expectation of being a leader within the department by leading process improvements, new initiatives as well as training for junior colleagues. Minimum Qualifications & Experience: Graduate in a clinical or life sciences related field. At least eight to ten years experience in a similar role working in the research, pharmaceutical industry or a related field. Responsibilities: Member of the project team reporting to the Project Manager for integrated projects, the Senior Clinical Data Manager is responsible for planning, conducting, and managing all aspects of data management for a clinical trial according to the client specifications, protocol, project plan, Data Management Plan, relevant GCDMP guidelines, regulatory requirements, and SOPs. Determination of project feasibility from a data management perspective. Understand the requirements of the project agreement and scope to ensure that Novotech performs these services as required. If full service, then collaborate with PM to ensure appropriate mitigation and contingencies are initiated. May function as Project Manager for stand-alone data management projects. Participates in project team meetings as required. Input into the preparation of RFPs in liaison with BD and the clinical team. Liaison with the project team and client for preparing and maintaining Data Management Plans. Responsible for all aspects of data management including: Design and review of database structure, validation rules and consistency checks. Operation of Clinical Data Management Systems. All data cleaning/validation tasks. Development of all key Data Management Documents. Liaison with client companies / monitoring staff as appropriate, ensuring effective study communication with internal and external stakeholders. Liaison with external service providers on Data Management projects as appropriate. Assist in the development of protocols as required. Supervision and training support for junior and contract Data Management staff as required. Adherence to company Quality Policy and procedures applicable to fulfilling job responsibilities. Active contribution in Data Management process improvement including identification of and participation in process improvement initiatives. Perform accurate study financial projections and maintain monthly project financials. Ensure changes in scope are identified and actioned accordingly. Provide expert assistance and input into internal cross-functional projects including clinical research and regulatory affairs, as assigned. Project management of internal IT-based company projects as assigned (e.g., intranet development, client database applications etc.). Active contribution to company business development initiatives, including involvement in the implementation of data management plans for business development in the company in general. Participation in industry fora (conferences, professional association committee work, etc.) as a means of professional development as well as promotion of Novotech s image in industry.

Responsibilities: * Prepare clinical study reports and protocols. * Ensure compliance with ICF and ICH-GCP guidelines. * Collaborate on clinical research projects. * Write medical communications for regulatory submissions. Provident fund

We are seeking a Senior Specialist in Obstetrics & Gynecology to join our team in India. The ideal candidate will have substantial experience in providing high-quality medical care to patients, including prenatal and postnatal care, as well as surgical procedures. The role requires a compassionate approach, strong clinical skills, and the ability to work collaboratively within a multidisciplinary team. Responsibilities Conduct regular check-ups and examinations for patients in obstetrics and gynecology. Manage prenatal and postnatal care for expectant mothers. Perform gynecological surgeries and procedures as necessary. Provide counseling and education to patients regarding reproductive health. Collaborate with other healthcare professionals to ensure comprehensive patient care. Stay updated with the latest developments and best practices in obstetrics and gynecology. Skills and Qualifications MBBS degree with a specialization in Obstetrics & Gynecology. 4-6 years of relevant experience in a clinical setting. Strong knowledge of prenatal and postnatal care practices. Proficient in performing gynecological examinations and surgeries. Excellent communication and interpersonal skills to interact with patients and healthcare teams. Ability to work in a fast-paced environment and manage multiple cases effectively. Familiarity with electronic medical records (EMR) systems and healthcare software.