Clinical Data Manager Jobs

As a Senior Biomedical Engineer, you will play a critical role in the development and improvement of medical devices and technologies. Your work will ensure that these products are safe, effective, and meet regulatory standards.Key Responsibilities:- Design and Development: You will create and improve medical devices, ensuring they work effectively and are safe for patients.- Testing and Evaluation: You will conduct tests on new products to evaluate their performance and identify any issues that must be resolved before release.- Regulatory Compliance: You will ensure that all products meet local and international safety regulations, preparing necessary documentation for regulatory approval.- Collaboration: You will work closely with teams including engineers, doctors, and manufacturers to gather insights and enhance product design.- Technical Support: You will provide expert assistance to healthcare professionals, helping them understand and utilize medical equipment properly.Required Skills and Expectations:You should have a background in biomedical engineering and possess practical experience of 1 to 7 years in the field. A strong understanding of medical device design principles, regulatory standards, and testing procedures is essential. Proficiency in relevant software tools for modeling and simulation is expected. Excellent communication skills will be necessary for effective collaboration with diverse teams and stakeholders. You should be ready to work full time from the office in Australia, contributing to innovative medical solutions that improve patient care.

Organizing Kick-off meetings with the client co-ordination with the functional Head. Responsible for allocating the project/Study to team members. Responsible for Review and Internal approval of Data Management Plan (DMP), Case Report Form (CRF), and Edit check Specification Document (ESD). Responsible for Review and Internal approval of Data Entry Guidelines, Self-Evident Correction Document (SEC). Internal approval of Annotated CRF (aCRF) and Functional Design Specification (FDS) Document. Responsible for preparing and training the SOPs. Responsible for approval of database screens, Edit checks designed in database and DCF/Query tracker. Internal Quality Control for all Data Management Documents like Data Management Plan, Annotated CRF, Functional Design Specification Document, and Edit check Specification Document. Responsible for Issuing the Database Test Certificate. Responsible for Database Lock and Unlock procedures. Responsible for exporting the data to SAS team for analysis. Responsible for Review and approval of Master Data Management File (MDMF). Responsible for Data Management Presentation in Investigator meeting. Providing inputs for proposal development in co-ordination with the Function Head.

Position: Research And Development ApprenticeshipEligibility: LGBT Applicants Only + B.Pharm/M.Pharm (2022, 2023 or 2024 pass outs) + Bangalore City candidate*The above 3 parameters in Eligibility will be considered ONLY*Qualification: (2022, 2023 & 2024 Pass Outs) B. Pharm / M. PharmStipend: INR 25,000 per month (in hand)Duration: 12 monthsCTA: Depending on performance maybe be converted into full time resources at the end of the internship periodWork Timing, General Shift: 9AM to 5 PMLocation: Bengaluru OnlyWho Can Apply - LGBT+ (Lesbian, Gay, Bisexual, Transgender+) Pharma Job Seekers who are based in and around Bengaluru only Role Requirements-Good English language skills written and verbal particularly in scientific/medical terminologyAbility to evaluate data and draw conclusions with appropriate guidance from senior team members or managerGood attention to detailGood interpersonal, presentation and communication skillsService-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environmentComputer proficiency, IT skills, the expertise and ability to work with web-based applicationsGood level of flexibility and ability to prioritize workIf you belong from LGBT Community then please send CVs at pamela@thepridecircle.com

Job Responsibilities - Able to detect, interpret and update specific reasons to see the Patient and then treatment related information. Able to review the medical information such as 'Physician's Plan of Action', 'Lab Reports', and / or other related information per client specification. Able to create precise and informative summaries of Patient's Medical Records. Interaction with managers regarding problem solving and understanding the process.Skills Required Analytical skillsDetail orientationAbility to perform multitaskAbility to prioritize the workGood command on English (oral and written communication skills)Computer knowledge.

Essential Functions Review and assure the quality, integrity, accuracy, and completeness of clinical trial data based on project specific guidelines. Develop and maintain a library of effective data quality checks. Review data exports and reports to identify, investigate, and reconcile data discrepancies with Clinical Operations staff and/or clients Data Managers. Prepare, review, and upload appropriate Data Management documents to the Trial Master File Perform thorough development testing of the datasets prior to release to production, inclusive of creating test scripts and execute testing as applicable. Author Data Transfer specifications (DTS) for incoming and outgoing data files. Collaborate effectively and build productive relationships across the global operations team. Performs other job-related duties as assignedQualifications 3+ years of data management experience in the clinical trials industry BS/BA degree or professional experience equivalent. Demonstrated successful experience in all relevant clinical data management activities in a Pharmaceutical or CRO setting. Working knowledge of clinical trial research, including FDA, GCP/ICH guidelines, GDPR, CDISC/SDTM standards and 21 CFR Part 11 Experience working with EDC systems, e.g., Medidata Rave or Oracle Inform Familiarity with industry wide coding dictionaries such as MedDRA is a plus Experience with relational databases and XML a plus Excellent written and oral communication skills. Excellent analytical and problem-solving skills Ability to function independently. Ability to prioritize and handle multiple tasks and projects concurrently

Job Responsibilities1). Creation of Data sheets & Managing the current data sheets.(All kind of data of the company to be managed)2). Managing all the data on google drive3). Train about the usage of google drive & sheets to the users4). Creation of complex sheets of data/Systems into one (Mergingand creating & collaborating data sets)5). Google script writing & automating the processes of thecompany as per management guidelines6). Must know FMS, PMS, IMS (BMP Programme) Rahul JainCoursePreferred Nice to have EducationBCA / MCAExperienceShould have in depth knowledge of -:excel VBA, Excel Formulas, Googleapp script, Google Scripting, Googledata studio, Google sites & JAVA scriptFMS, PMS, IMS, Checklists (Rahul Jain Course)Behavioral traitsCalm & Composed. Systematic.Gender MaleSalary range 40-48,000 per monthExpected starting date: Immediate

Position Clinical Research CoordinatorQualification B.PharmExperience - Above 1YearsTiming - General ShiftSalary Based upon PerformanceLocation ChennaiLicence: Pharmacy Lice(Only B. Pharm is eligible for this Job)Job Description Clinical Research Coordinator: To have the good knowledge of regulations and GCP guidelines. Ability to communicate properly between the physician, patient & the site head. Assist the Site Head in the managing the Site to ensure ethical conduct of research activities. Assist Site Head in evaluates protocols, policies and procedures regarding research projects and studies. Maintains pertinent records and documentation. Provide guidance to CRC in Screening including informed consent process, randomization, enrolment & follow-up (including Telephonic Follow-up) process & procedures. Maintenance of Investigator Master File as per Good documentation practices & SOP including generation of source documents. Oversight of Site Initiation Visit, Monitoring Visits, Site Closeout Visit. CRF, e-CRF entry, Data Query resolution. Assist the pharmacist in drug accountability and temperature maintaining logs. Monitoring Sr. CRC and CRC in maintaining the accountability of study materials and in scheduling study procedures. Endow the required file notes, weekly and monthly and monthly report to the reporting authority. Tracking the status of all study activities. Report to the Site Head daily and take advice for further action. Delegate the work to Senior/Junior/Trainee CRCs as per the requirement.Job Types: Full-time, PermanentSalary: ?10,000.00 - ?15,000.00 per month

We are looking for 100 Clinical SAS Programmer/ Biostatistician/ Clinical data coordinator Posts in Chennai with deep knowledge in Clinical SAS Programmer,Clinical Data Manager,Biostatistics and Required Educational Qualification is : Other Bachelor Degree

Organizing Kick-off meetings with the client co-ordination with the functional Head. Responsible for allocating the project/Study to team members. Responsible for Review and Internal approval of Data Management Plan (DMP), Case Report Form (CRF), and Edit check Specification Document (ESD). Responsible for Review and Internal approval of Data Entry Guidelines, Self-Evident Correction Document (SEC). Internal approval of Annotated CRF (aCRF) and Functional Design Specification (FDS) Document. Responsible for preparing and training the SOPs. Responsible for approval of database screens, Edit checks designed in database and DCF/Query tracker. Internal Quality Control for all Data Management Documents like Data Management Plan, Annotated CRF, Functional Design Specification Document, and Edit check Specification Document. Responsible for Issuing the Database Test Certificate. Responsible for Database Lock and Unlock procedures. Responsible for exporting the data to SAS team for analysis. Responsible for Review and approval of Master Data Management File (MDMF). Responsible for Data Management Presentation in Investigator meeting. Providing inputs for proposal development in co-ordination with the Function Head.

Organizing Kick-off meetings with the client co-ordination with the functional Head. Responsible for allocating the project/Study to team members. Responsible for Review and Internal approval of Data Management Plan (DMP), Case Report Form (CRF), and Edit check Specification Document (ESD). Responsible for Review and Internal approval of Data Entry Guidelines, Self-Evident Correction Document (SEC). Internal approval of Annotated CRF (aCRF) and Functional Design Specification (FDS) Document. Responsible for preparing and training the SOPs. Responsible for approval of database screens, Edit checks designed in database and DCF/Query tracker. Internal Quality Control for all Data Management Documents like Data Management Plan, Annotated CRF, Functional Design Specification Document, and Edit check Specification Document. Responsible for Issuing the Database Test Certificate. Responsible for Database Lock and Unlock procedures. Responsible for exporting the data to SAS team for analysis. Responsible for Review and approval of Master Data Management File (MDMF). Responsible for Data Management Presentation in Investigator meeting. Providing inputs for proposal development in co-ordination with the Function Head.

Organizing Kick-off meetings with the client co-ordination with the functional Head. Responsible for allocating the project/Study to team members. Responsible for Review and Internal approval of Data Management Plan (DMP), Case Report Form (CRF), and Edit check Specification Document (ESD). Responsible for Review and Internal approval of Data Entry Guidelines, Self-Evident Correction Document (SEC). Internal approval of Annotated CRF (aCRF) and Functional Design Specification (FDS) Document. Responsible for preparing and training the SOPs. Responsible for approval of database screens, Edit checks designed in database and DCF/Query tracker. Internal Quality Control for all Data Management Documents like Data Management Plan, Annotated CRF, Functional Design Specification Document, and Edit check Specification Document. Responsible for Issuing the Database Test Certificate. Responsible for Database Lock and Unlock procedures. Responsible for exporting the data to SAS team for analysis. Responsible for Review and approval of Master Data Management File (MDMF). Responsible for Data Management Presentation in Investigator meeting. Providing inputs for proposal development in co-ordination with the Function Head.