34 Protocol Designing Jobs

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Position: Medical Writer I / Senior Medical Writer Experience Required: 6 to 8 years (CRO preferred / Pharma) Qualification: M. Pharm (Pharmacology) / Pharm D Location: Remote (Work from Home) Job Type: Full-time, Remote Key Responsibilities (Must-Have Skills) - Independently prepare, review, and finalize Protocols - Concept Sheets - Investigators Brochure (IB) - Informed Consent Forms (ICF) - Case Report Forms (CRF) - Ensure compliance with regulatory requirements Nice-to-Have Skills - Module 2 (CTD) Documents - Regulatory briefing documents - Manuscripts and publications - Scientific presentations / posters - Experience with global teams Role & responsibilities Act as the primary point of ...

Ficial: Negotiating clinical trial budget with the CROs/Investigators. Operational: Preparation and amendment of SOPs for clinical trial activities. Clinical trial sites qualification and selection. Tracking payments made to the CRO/Investigators/Ethics Committees Protocol Designing Case Report Form (CRF) Designing Preparation of dossier/documents for Regulatory submission Addressing DCG(I) queries Co-ordination with the CRO for timely completion of the clinical trial activities Protocol training of the study staff Monitoring and auditing clinical trial sites Coordinate with investigators for conduction of clinical trials Archiving study documentation and correspondence Source Data Verificat...

- Customer Engagement as SME continuous support in both pre-sales and post-sales phases - Provide deep subject matter expertise on Clinical Trial processes and related systems. - Support BD team with system demonstrations, domain insights, Required Candidate profile - Experience in Clinical Trials, EDC, CDM, Clinical systems Trails Solutions. - Understanding of clinical research workflows and regulatory Perks and benefits - GPA and 5 days week - Term plan

Senior Medical Writer - Clinical Research (BA / BE Studies) @ Vimta Labs Ltd, Hyderabad Experience: 8-12 years in Medical writing field in Clinical Research BA/BE studies CTC : As per market standards Report to: Principal Investigator Clinical Primary Responsibilities: 1. Ensures that Good Clinical Practices (GCP) and NDCT (New Drugs and Clinical Trials Rules) are followed. 2. Writing and developing BA/BE and clinical trail protocols. 3. To perform literature search and preparation of feasibility. 4. Preparation of study specific informed consent forms (ICFs), case report forms (CRFs) and blood sample forms. 5. Preparation of clinical study reports (CSRs), DBE/summary tables, CS-BE tables an...

- Collaborate with project managers to define scope, timelines, and deliverables - Ensure timely and effective execution of clinical trial software solution projects - Provide consulting for CTMS platform implementation, configuration Required Candidate profile - Advise on solution architecture, workflows, and usability enhancements in CTM systems - Validate the alignment of software features with clinical workflows and regulatory requirements Perks and benefits -GPA &term Insurance -5 days week -open to discuss

A Day in the Life Responsibilities may include the following and other duties may be assigned. Candidate have 3+ years of experience into clinical data management. Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review. Design and implement clinical protocols and data collection systems. Develops systems for organizing data to analyze, identify and report data and trends. Manages data management issues by reviewing protocols for cross-project consistency, and identifying standard Case Report Form (CRF) modules to meet objectives. Develops data quality plans. Provide early strategic inpu...

Responsibilities Ensure secure code for AI-driven and web-based systems and cyber security to protect data and applications. Develop and optimize AI prompts for real-world applications. Collaborate globally across time zones on live projects.

Responsibilities: * Lead clinical trials from start to finish * Manage site selection, initiation & monitoring * Ensure compliance with ICH-GCP guidelines * Design protocols & review applications Provident fund Office cab/shuttle Health insurance Annual bonus

A Day in the Life Responsibilities may include the following and other duties may be assigned. Candidate should have minimum 10 years of experience into clinical data management. Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review. Design and implement clinical protocols and data collection systems. Develops systems for organizing data to analyze, identify and report data and trends. Manages data management issues by reviewing protocols for cross-project consistency, and identifying standard Case Report Form (CRF) modules to meet objectives. Develops data quality plans. Provide early...

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...

Responsible for study design, edit specifications and system configurations. The Clinical database designer is accountable for associated quality and timely delivery of assigned study design components in collaboration with other project stakeholders. Essential Functions Interprets the study protocol. Design and update the eCRF. Create and update Edit Specification Document. Generate specifications for EDC build components (e. g. , Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal ...

Responsible for study design, edit specifications and system configurations. The Clinical database designer is accountable for associated quality and timely delivery of assigned study design components in collaboration with other project stakeholders. Essential Functions Interprets the study protocol. Design and update the eCRF. Create and update Edit Specification Document. Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal De...

Position Description: This is a great opportunity to join a winning team. CGI offers a competitive compensation package with opportunities for growth and professional development. Benefits for full-time, permanent members start on the first day of employment and include a paid time-off program and profit participation and stock purchase plans. We wish to thank all applicants for their interest and effort in applying for this position, however, only candidates selected for interviews will be contacted. No unsolicited agency referrals please. Your future duties and responsibilities: Qualification & Skills Strong knowledge on Networking Concepts WAN/LAN/WLAN/ SDWAN MAN/MPLS/VPN, TCP/IP, Switche...

A Day in the Life Responsibilities may include the following and other duties may be assigned. Minimum 6+ years of experience. Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review. Design and implement clinical protocols and data collection systems. Develops systems for organizing data to analyze, identify and report data and trends. Manages data management issues by reviewing protocols for cross-project consistency, and identifying standard Case Report Form (CRF) modules to meet objectives. Develops data quality plans. Provide early strategic input into protocol design focused on dat...

Role & responsibilities Provide comprehensive medical and scientific expertise and oversight for clinical trials, ensuring study integrity and participant safety. Review and contribute medical input to study protocols, ensuring clinical feasibility, scientific rigor, and compliance with regulatory requirements and guidelines. Ensure strict adherence to clinical trial protocols through continuous monitoring and proactive management of ongoing studies. Prepare, critically review, and approve essential clinical trial documents across all phases, including Informed Consent Forms (ICF), Statistical Analysis Plans (SAP), Clinical Study Reports (CSR), Safety Management Plans, Medical Management Pla...

Job Description we're looking for a highly skilled Technologist, Software Engineering with over 10 years of experience to lead the host-side software stack for our high-bandwidth flash controller. In this role, you'll design and implement a high-performance PCIe kernel-mode driver for both Linux and Windows , along with a corresponding user-space library. This is a senior, hands-on role that requires a deep understanding of low-level systems and high-speed communication. Key Responsibilities Multi-OS PCIe Driver Development: you'll architect and implement high-performance PCIe drivers for both the Linux and Windows operating systems. This includes handling device enumeration, interrupt manag...

Job Description Were looking for a highly skilled Technologist, Software Engineering with over 10 years of experience to lead the host-side software stack for our high-bandwidth flash controller. In this role, youll design and implement a high-performance PCIe kernel-mode driver for both Linux and Windows , along with a corresponding user-space library. This is a senior, hands-on role that requires a deep understanding of low-level systems and high-speed communication. Key Responsibilities Multi-OS PCIe Driver Development: Youll architect and implement high-performance PCIe drivers for both the Linux and Windows operating systems. This includes handling device enumeration, interrupt manageme...

Position Description: This is a great opportunity to join a winning team. CGI offers a competitive compensation package with opportunities for growth and professional development. Benefits for full-time, permanent members start on the first day of employment and include a paid time-off program and profit participation and stock purchase plans. We wish to thank all applicants for their interest and effort in applying for this position, however, only candidates selected for interviews will be contacted. No unsolicited agency referrals please. Your future duties and responsibilities: Qualification & Skills Strong knowledge on Networking Concepts WAN/LAN/WLAN/ SDWAN MAN/MPLS/VPN, TCP/IP, Switche...

Role & responsibilities Clinical trial designing, protocol inputs for generic products and their FDCs The position is to Lead team of scientists to accomplish activities related to clinical trial designing, monitoring, concluding and MMA. Phase trials I IV execution. NDDS product development. Define objectives/ sample size calculation for protocols of clinical trials. AE/ SAE monitoring & reporting. Site selection/ site evaluation. Training to investigators, guide the trial site for execution of the study as per expectation of protocol. Preferred candidate profile MD (Pharmacology) with 2-4 yrs of relevant experience. Interested candidates are requested to share their CVs on vilshashah@torre...

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 Formulation and Process Development Scientist, you will be responsible for the formulation and process development of Solid Orals, Liquid Orals, and Semi Solids dosage forms. Your main tasks will include designing protocols and development plans for new products, conducting formulation trials, and evaluating stability data to finalize formulation compositions. You will also be involved in tentative costing Bill of Materials (BOM) and trial BOM preparation for trial execution. Additionally, you will prepare supporting documents for stability studies, resolve product stability issues, and develop manufacturing processes for R&D formulations to ensure successful technical transfer for larg...

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

Responsible for study design, edit specifications and system configurations. The Clinical database designer is accountable for associated quality and timely delivery of assigned study design components in collaboration with other project stakeholders. Essential Functions Interprets the study protocol. Design and update the eCRF. Create and update Edit Specification Document. Generate specifications for EDC build components (eg, Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Desi...

Responsible for study design, edit specifications and system configurations. The Clinical database designer is accountable for associated quality and timely delivery of assigned study design components in collaboration with other project stakeholders. Essential Functions Interprets the study protocol. Design and update the eCRF. Create and update Edit Specification Document. Generate specifications for EDC build components (eg, Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Desi...