37 Data Review Jobs - Page 2

At Burns & McDonnell India (BMI OGC), you'll be joining the ranks of our Piping Design & Engineering team. You'll report to department & functional managers, and your focus? The engineering design of projects spanning across sectors such as Oil, Gas, Chemicals, Petrochemicals, Renewable Fuels, Decarbonization, and Carbon Capture. And these projects aren't limited to a local scale; they are positioned globally, reflecting our worldwide impact. You'll be a part of our vibrant Oil, Gas, and Chemicals (OGC) Global Practice, a thriving collective of around 500+ professionals. This dynamic group lives and breathes engineering, procurement, and construction projects across various industries - Refining, Midstream & Logistics, Petrochemical, and Chemicals. So, are you ready to take on challenges that shape industries and transform lives? Dive into the exciting world of Burns & McDonnell India, where your contribution will be part of our global footprint. Roles & Responsibilities: Analysis experience of Static & Rotary equipment. Nozzle load limit check, flange definition for flange leakage qualification, piping specials, and accuracy checking of Input. Analysis of Stress model for Code stresses check [Sustain, Expansion, Occasional stresses], Displacement, Flange Leakage qualification using ASME Sec VIII, Equipment Nozzle loads/ Pipe Support qualification wrt. to vendor allowable / as per applicable code / Qualification using Nozzle-pro (where applicable). Define Pipe Support requirement as per analysis and its support tagging and marking the stress comments on Isometrics. Preparation of support loads for Civil & Structural group. Preparation of documentation for Independent Quality Review. Preparation of procurement specification with log sheet for Piping Specials like Cold Shoe, Spring, Rod Hanger, Struts, Snubbers, Expansion joints, etc., their TBA, and vendor drawing review. Position may require interface and coordination with other engineering disciplines, designers, and detailers locally in the Mumbai office as well as remotely in various offices in the United States. Knowledge in Piping engineering, Conceptual pipe routing and layout, Pipe and Valve materials specification preparation, piping specials, technical bid evaluation, Vendor data review and approval, isometrics checking, and approval would be an added advantage. - Bachelor’s Degree in Mechanical/Chemical engineering 5-12 years of experience in detailed stress analysis associated with Energy/Oil & Gas projects. Advanced understanding and proficient experience of design software such as Caesar II, knowledge of AutoPipe is added advantage. Hands-on experience of Navisworks, SPR and Excel to develop design deliverables is preferred. Engineers having experience in preparation of Piping Material Specification will be preferred. Familiar with Energy/Oil & Gas industry codes and standards including ASME & API.

Experience of reviewer data review of method validation. Document review like STP, Protocols and Reports of AMV , verification. Monitoring of daily activities Preparation and review of Validation Protocol, Report, SOP and Specifications, analysis.

Position Summary: Ensure the client receives quality data in a timely manner by reviewing laboratory documentation, generated data, calculated results, and final reports for accuracy, clarity, and adherence to GMP and/or GLP regulations, and evaluating problems/system failures to achieve efficiency gains Essential Duties and Responsibilities: Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Processing of simple and complex routine and non-routine data (for 3 or more areas) according to departmental, corporate, and client SOPs; read and understand analytical procedures; make sure all work is performed according to GLP/GMP requirements; perform complex calculations Communication in writing and in person with laboratory personnel in an intelligent and clear manner Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, integration review, compound evaluation, chemical identification, and other subjective review based on testing performed; perform complex calculations to verify results Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology May serve as technical advisor for analysts with regard to QA/QC of data Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees Attention to details Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications Education/Experience (BMQ): Masters degree in a pharma / science-related field with at least 8-10 years of experience or Ph. D degree (preferred) with 5 years in Bio/Pharmaceutical Analysis experience with knowledge of regulatory requirements and data review responsibilities Experience with chromatography and mass spectrometry analytical techniques (HPLC, GC, LC/MS, GC/MS) Experience identifying unknown compounds by mass spectrometry (ideally by LC/MS-TOF and/or LC/MS-QTOF) Additional Preferences: Experience with Agilent MassHunter software Experience with extractables and leachables testing Knowledge of USP/EP compendia, and laboratory software applications such as Waters Empower software, LIMS, Electronic Notebook is preferred Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience Strong Math Skills Logical Thinking, Good Reasoning Ability Motivation to excel Coaching/mentoring of peers

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Specialist Qualifications: Bachelor of Pharmacy Years of Experience: 7 to 11 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.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. The role may require you to 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 role may also need expertise in managing clinical data management projects. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Roles and Responsibilities: Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred. o Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. o Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders. o Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery. o Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. o Good analytical and communication skills. Qualifications Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert 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.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Clinical Data Analyst Location: Bangalore, Hyderabad, Mumbai Education: Science Graduate Experience: 3+ years Notice Period: Immediate Joiners Preferred Skills: SQL, SAS, MACROS, Lifesciences, Clinical domain, Clinical trials, data reporting/review

Data Analyst II Job Description Manage data cleaning activities for specified clients/studies Liaise directly with client/CRO DMs to develop a query management strategy during study start-up Enact and maintain data cleaning schedule in accordance with the established query management strategy ¢ Maintain visibility to data lock schedules and ensure reconciliation is complete prior to data lock periods ¢ Ensure a seamless communication and follow up with our selected external client and internal clients. ¢ Analyze client data discrepancies. Update database accordingly to the clients needs and in compliance with the GCP rules when appropriate. ¢ Lead the communication with the other departments in relation to the discrepancy solving until resolution. ¢ Provide direct answers to the selected external client or internal clients and provide advice when the request is not directly feasible. ¢ Negotiate the timelines when needed. ¢ Involve selected external clients or internal client in decision making to ensure clients needs are being considered. ¢ Act as primary strategic representative between selected external clients and other Covance departments in the scope of the data reconciliation. ¢ Review the study Statement of Work to ensure compliance of the request with the protocol when appropriate. ¢ Perform quality checks on data revisions and answers provided to clients. ¢ Generate and review Covance database reports and resolve issues as needed. ¢ Lead escalation of issues that may impact resolution of the discrepancies on time. Manage workload and priorities to ensure all clients deadlines are respected. ¢ Work in a team-oriented, global environment with the focus on customer service, both internal and external. ¢ Assist and support management in the implementation of global processes and procedures ensuring seamless integration. ¢ Responsible for effective and timely adherence to management communications, meeting and procedures. ¢ Support a culture of continuous improvement, quality and productivity. ¢ Assist management team with audits, reportable issues, CAIRs, and other quality issues as needed. ¢ Responsible for providing expert technical and administrative support to CLS data processing systems and act as a lead in resolving process and or application issues as necessary.

Review and approval of analytical documents generated in the QC lab (e.g., STPs, COAs, protocols, reports). Perform thorough investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents in coordination with QC. Ensure timely closure of investigations with proper root cause identification and implementation of CAPA. Ensure compliance with cGMP, ICH guidelines, and other regulatory requirements. Support data integrity initiatives and audit readiness in the QC laboratory. Participate in internal and external audits, including those by USFDA and other regulatory bodies. Review and trend analytical data to ensure ongoing process verification and product quality. Collaborate with cross-functional teams (QC, Production, Regulatory Affairs, etc.) for continuous improvement. Desired Candidate Profile: Education: B.Pharm / M.Pharm / M.Sc in Chemistry or related field Experience: 10+ years of experience in Analytical Quality Assurance or QC in a pharmaceutical manufacturing environment, preferably in oral solid dosage (tablets) Hands-on experience in handling analytical investigations in a QC lab Experience in facing USFDA or other international regulatory audits Strong understanding of cGMP, ICH guidelines, and data integrity requirements Good communication and documentation skills

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Specialist Qualifications: BSc/Master of Pharmacy Years of Experience: 7 to 11 years Language - Ability: English(International) - Expert 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.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert 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.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert 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.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred.

Preferred candidate profile Looking for a candidate with 2 to 4 years of work experience as QC analyst /AQA reviewer in reputed pharma companies. Should have Knowledge of handling/analytical data review of HPLC, FTIR, UV spectrophotometer, KF Autotitrator, Dissolution apparatus. Have Basic knowledge of CGMP, GDP, Data integrity. Should have Basic knowledge of OOS (Out of specification), OOT (Out of rend), OOC (Out of calibration).