29 Protocol Review Jobs

Role & responsibilities Preparation and Compilation of Study Proposal Synopsis. Literature survey and preparation and review of Clinical Study Protocols as per sponsor and / or applicable regulatory authorities. Preparation and Compilation of Clinical Study reports. Regular interaction with the Investigators of various departments for protocol inputs. Preparation of informed consent documents and protocol associated appendices. Handling and providing responses to sponsors and regulatory queries. Responsible for Review of regulatory guidelines with the current requirements for clinical research services related activities. Review procedures for pharmacy operations. Preferred candidate profile...

As a Protocol Review Specialist, you will play a crucial role in the clinical trials process. Your responsibilities will include reviewing protocols, responding to queries and clarifications from EC/IRB, answering medical questions, attending drug safety meetings, reviewing AE/SAEs, and providing protocol training to site staff, CRAs, etc. during investigator meetings. Key Responsibilities: - Reviewing protocol and providing suggestions to enhance the process - Responding promptly to queries/clarifications from EC/IRB - Addressing medical questions from sites or project teams effectively - Attending important drug safety meetings and external meetings - Thoroughly reviewing and documenting A...

As a Clinical Data Associate II at our company, your role involves providing data management support and assistance throughout the clinical trial data management process for assigned projects. You will follow Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans. Your responsibilities include but are not limited to: - Supporting the Lead DM as a back-up or team member to ensure continuity and timely task completion - Performing data entry for paper-CRF studies when necessary - Conducting quality control of data entry - Developing CRF specifications from the clinical study protocol and coordinating feedback - Assisting in building clinical databases - Conductin...

Role Overview: As a Tablets Production Officer at Khatraj Plant, your main responsibility will be overseeing the tablets production process, including granulation, compression, coating, and packing department. You will be required to manage the production activities efficiently to meet the production targets by utilizing available resources effectively during your shift. Key Responsibilities: - Responsible for tablets granulation, compression, coating, and packing department. - Execute production activities in a shift by efficiently managing available resources to achieve production targets. - Maintain standard process parameters as per BMRs and other supporting documents to ensure productio...

Eligibility Criteria: • MBBS graduates only from Indian institutes • Must hold a valid Medical Registration Certificate • Willing to Work with us for At least 3-4 Years • Freshers & Experienced candidates are welcome Location: Miyapur, Hyderabad Role: Medical Monitor Work Mode: WFO (Full Time) Responsibilities: Provide protocol and therapeutic area training to study teams (both internal and external). Provide response to PI/site/EC queries. Prepare medical monitoring plan Review of Protocol deviation and Categorization of the same. CSR/SMP/SAP review Review study enrolled subject reports for eligibility in coordination with Project Manager/Designee, if required. SAE management if any, follow...

As a Senior Clinical Data Associate at [Company], you will be responsible for providing data management support and assistance throughout the clinical trial data management process. Your role will involve following Standard Operating Procedures (SOPs) and regulatory directives to ensure the successful completion of assigned projects. Some key responsibilities include: - Supporting the Lead DM as a back-up and/or team member to ensure tasks are performed in a timely manner - Performing data entry for paper-CRF studies and conducting quality control of data entry - Assisting in developing CRF specifications and coordinating the review/feedback from stakeholders - Building clinical databases an...

Eligibility Criteria: • MBBS graduates only from Indian institutes • Must hold a valid Medical Registration Certificate • Freshers & Experienced candidates are welcome Location: Miyapur, Hyderabad Hyderabad Role: Medical Monitor Work Mode: WFO (Full Time) Responsibilities: Provide protocol and therapeutic area training to study teams (both internal and external). Provide response to PI/site/EC queries. Prepare medical monitoring plan Review of Protocol deviation and Categorization of the same. CSR/SMP/SAP review Review study enrolled subject reports for eligibility in coordination with Project Manager/Designee, if required. SAE management if any, follow up with sites/ investigator for SAE up...

As a Clinical Research Coordinator at INPHOG, your role will involve planning, directing, and coordinating clinical research projects. You will be responsible for evaluating and analyzing clinical data to ensure the successful implementation of various sponsored and academic studies. Your key responsibilities will include: - Facilitating and coordinating daily clinical research trial activities - Reviewing and comprehending assigned protocols - Interviewing families/patients - Collecting and entering data - Completing case report forms - Ensuring timely and accurate data entry - Developing relationships with key individuals in hospitals - Collaborating with clinical research and support team...

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical...

Role & responsibilities 1.Stability Studies Management: Planning and management stability studies, Comparative Stability and Forced Degradation (FDS) Studies, Reference product age related studies of all the projects. Compilation of stability data, interpretation, and data trending. To review the data, related DRS and LNBs etc. 2. Drafting / review / approval of operational SOP, LP, SLP and Stability Protocols, Summary Sheets, Reports as required. 3. Planning and management of the IRS: Planning and management for establishment of internal reference standards. Management of IRS stability studies, issuance, compilation and trending the retrospective data of the established internal standards. ...

We are seeking a dynamic and experienced Quality Control (QC) Manager to lead and manage QC operations, ensuring that products and processes meet stringent quality and regulatory requirements. The ideal candidate will possess deep technical expertise, a strong leadership background, and a commitment to data integrity and continuous improvement within the life sciences industry. A detail-oriented professional with expertise in Nitrosamines/NDSRI method development and validation by LC-MS focused on detecting and quantifying nitrosamine impurities in APIs and Finished Dosage Forms. You will contribute to method development, validation, instrument calibration, and document preparation while ens...

The Head Clinical Operations & Clinical Strategy role in Bangalore requires a highly skilled and independent professional with expertise in clinical research. This individual will be responsible for supporting Global Research & Development activities related to clinical trials by providing excellent data interpretation, creative thinking, and persuasive communication. Working closely with the senior leadership team of R&D, the role involves determining clinical strategies for various products and markets within the global portfolio. Additionally, this position plays a key role in evaluating external partnership opportunities through due diligence assessments. Responsibilities include oversee...

Review Validation protocol, Chromatography Raw Data, Validation, Study Report, BA Report, in process report, responsible for providing response to QA. Required Candidate profile knowledge of Bioanalytical Data Review Prefer Ready to work in first and second shift MSc ,M.Pharma / B.Pharma with Bioanalytical data review experience will prefer. Perks and benefits 5 Days week, Bus Facility, Birthday Leave, 28 PL

The Clinical Data Associate II role involves providing data management support for clinical trial projects from study initiation to post-database lock, while adhering to SOPs, regulatory guidelines, and study-specific plans. Your responsibilities include supporting the Lead DM, performing data entry, quality control, developing CRF specifications, building and testing clinical databases, and maintaining data management documentation. You will also be involved in training clinical research personnel, reviewing and querying trial data, conducting medical coding, and assisting with various data-related activities such as SAE/AE reconciliation and vendor coordination. Additionally, you may contr...

Role & responsibilities Job description Perform protocol for drug excipient compatibility studies and submit the protocol for review and approval Complete lab. experiment hands-on independently (Lab scale to exhibit batch and query handling). Dosage forms experience: Injectables predominantly more than 90% in career. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development. Carry out /Support Scientific literature search (CVM/USFDA/Daily-med/publications). Follow good laboratory practices, good documentation practices (online LNB writing) and maintain the logbooks and forms for equipment/instruments. Compilation, int...

Job Descriptions : Job Title: Ass. Manager Clinical Research & IPR Job Location: - Plot No. 214, Borsad - Tarapur Road, Ta: Petlad, Dist: Anand, Gujarat, India. Department: R&D / Regulatory Affairs Experience: 7 to 10 years in nutraceuticals, clinical research, and IPR. Industry: Nutraceutical / Food / Pharma Manufacturing Reports To: Head of R&D / Director Job Type: Full-Time Company Profile: - Pharmanza Herbal Pvt. Ltd. is one of the few companies which is focusing on standardizing and proving the efficacy of Herbal products. Our strong supplier base, fully equipped R&D facility, FDA approved manufacturing facility, infrastructure for conducting human trials as well as our formulations uni...

As a Quality Assurance Specialist, your responsibilities will include reviewing all Master Production and Control Record (MPCR) and Batch Packing Records (BPR), as well as Standard Operating Procedures (SOPs). You will need to meticulously review specifications and testing procedures for starting materials, packaging materials, in-process products, finished products, working standards, and stability (Shelf life). Additionally, you will be tasked with reviewing Out-of-Specification (OOS) investigation reports and participating in investigations related to complaints, vendor audits, external testing laboratories audits, and the subsequent Corrective and Preventive Actions (CAPA). You will also...

Responsibilities: Prepare clinical study reports, protocols & newsletters Design medical affairs strategies Conduct literature reviews & ICH compliance checks Write scientific documents with CRF & KOL input Protocols, abstracts, posters, manuscripts Provident fund

As a Manager of Clinical Research at Teva Pharmaceuticals, you will play a crucial role in ensuring the proper conduct of studies related to BA/BE Studies. Your responsibilities will include complying with all applicable regulations, completing necessary forms, and adhering to the GCP, EC/Sponsor agreed protocol, Lotus SOPs, regulatory requirements, and ethical principles. Before the study starts, you will review and provide timely inputs on the protocol, obtain ethics committee approval, and ensure that all study personnel are trained and aware of their obligations. You will be overall responsible for supervising study-related activities, providing timely inputs in the protocol and Informed...

Role & responsibilities Handled Microbiology QMS Activities. Should have experience in OOS,OOT protocol review Preferred candidate profile Male Candidate Preferred

Should have the experience in activities like QMS Activity, BMR Review, Change Control, Document Issuance, Vendor Qualification, Process Validation etc. Process validation / equipment Qualification protocol preparation and review Required Candidate profile Vendor qualification and validation

KEY TASKS & RESPONSIBILITIES : Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies. Utilize artificial intelligence...

The Clinical Data Associate II provides data management support and assistance in all aspects of the clinical trial data management process from study start up to post database lock for assigned projects under direct supervision. You will follow Standard Operating Procedures / Work Instructions (SOPs/WIs), regulatory directives, study specific plans, and guidelines. Your responsibilities include supporting the Lead DM, performing data entry for paper-CRF studies when necessary, conducting quality control of data entry, developing CRF specifications, assisting in building clinical databases, and maintaining quality controlled database build documentation. You will also specify requirements fo...

Role & responsibilities *Feasibility assessment/ new product evaluation *Literature review and BA/BE study designing *BE Study Monitoring *Preparation of documents for regulatory submission (i.e BENOC, Import license application etc.) *Establishment and maintenance of study documents *Document preparation for dossier submission (i.e clinical overview, non-clinical overview, summery tables etc.) *Review of BE study documents i.e protocol, reports, ICF etc. *Preparation/review of medical write up * Coordination for serious adverse event reporting and safety update to Regulatory agency Preferred candidate profile M.Pharm (Pharmacology) with 1-5 Yrs with relevant experience Interested candidates...

QC Reviewer / Sr. Research Associate: Role & responsibilities Review analytical raw data, calculations, and reports for accuracy, completeness, and compliance with approved specifications and methods. Ensure all laboratory documentation meets regulatory and internal quality standards (e.g., USFDA, EU-GMP, ICH, WHO, etc.). Review chromatographic data (HPLC, GC), wet chemistry reports, and other analytical test results. Verify results for routine analysis, stability studies, and validation reports. Check instrument calibration records and ensure compliance before reviewing analytical results. Identify and report any data discrepancies, deviations, or non-conformities. Review and verify entries...