6 Protocol Review Jobs

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Regulatory Affairs Manager in Clinical Research @ Vimta Labs Ltd, Hyd Experience: 8-12 years of Regulatory Affairs experience in Clinical Research Industry. CTC: Based on their current CTC. Job Description Regulatory Affairs Manager Primary Responsibilities: 1.. Manage the activities of Regulatory Affairs for clinical research and ensure the implementation of effective regulatory strategies. 2. CDSCO, CBN and NCB getting approvals as required for Vimta. 2. Provide regulatory input to strategic decision making; including prioritization, and external communications 3. Provide regulatory input to in-licensing evaluations and due diligence activities 4. Provide advice about regulations to manufacturers/scientists 5. Coordinate successful submissions and approval of all applications 6. Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil applicable regulatory and quality standards. 7. Plan, undertake and manage regulatory inspections 8. Keep up to date with national and international guidelines and customer practices 9. Develop and establish standard operating procedures that convey the best practices in the company 10. Collect, collate, and evaluate scientific data from a range of source. 11. Monitor and set timelines for licence variations and renewal approvals 12. Ensures that Good Clinical Practices (GCP) are followed. 13.Responding to any quality & regulatory issues related to clinical department and taking relevant corrective and preventive actions Secondary Responsibilities: 1. Ensure Quality Control review of protocols, ICF, CRF protocol amendments, Clinical Trial Reports, Investigator Brochures and regulatory submission documents. 2. Interpretation of data. 3. Preparation and Review of Clinical Study Report Interested candidates can share their resumes to keerthana.rojanala@vimta.com Contact: Keerthana

#hiring 'Sr. Principal Investigator (Head Clinical Operations)' for one of the reputed Organization into Lifesciences & clincial research industry Position Title: 'Sr. Principal Investigator (Head Clinical Operations) Education Qualification: MBBS/MD Pharmacology Experience: 15+ years Responsibilities:- Responsible for the end-to-end conduct of Clinical studies in accordance with Good Clinical Practices (GCP), Protocol & SOPs. Responsible to lead entire clinical operations as 'Sr. PI/ Head Clinical' Responsible for Clinical TAT, Quality, staff attrition rate and staff training. System upgradation and E-CRF implementation Regulatory and sponsor audit handling. Responsible for delivering full scope BA/BE, Biosimilar research studies. To co-ordinate the progress of study activities within various team components such as Principal Investigators, Medical Investigators, Screening coordinator's, CRA's, Pharmacists, Paramedical, Medical Writing, QC, & Finance. To assess & provide clinical feasibility of BE study To co-ordinate with PM & BD team to achieve completion of various tasks related to study in the agreed timelines. To ensure that the clinical staff are meeting with defined workload & maintaining quality through regular review. Responsible for the review of study Protocol, ICF, CRF. Responsible for the review of Clinical Study Report. To communicate & co-ordinate with Sponsors as and when required. To co-ordinate with Independent Ethics Committee as and when required. To review departmental SOPs for necessary revisions as and when required. Focus will be on the overall improvement & strengthening of system & processes. Responsible for the appropriate planning & scheduling of BE studies. Responsible to ensure the availability of sufficient eligible volunteers for the conduct of the study. Responsible to plan screening activity of volunteers as per protocol requirement. To Impart protocol training & to assign duty delegation to study personnels based on their qualification, experience, expertise & job responsibility. Identifying, recording, reporting & management of AE's & SAE's that may occur during the conduct of study. Monitoring the conduct of study for appropriate quality compliance & for timelines during various stages. To evaluate eligibility of volunteers as per Inclusion/Exclusion criteria. Appropriate selection of external vendors which plays vital role in the conduct of the study. To provide training to the clinical staff /study personnels as and when required to improve overall conduct of the study. Responsible for the management of clinical staff in accordance with organization's policies & applicable regulations. Responsibilities include planning, assigning & directing the tasks, appraising performance && guiding them for professional development If Interested than kindly share CV to: recruit.corp12@apexservices.in

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

Role & responsibilities: Review and approve pharmaceutical development study protocols, ensuring they meet regulatory requirements and company quality standards. Critically evaluate study reports to ensure data accuracy, completeness, and compliance with established protocols and industry standards. Collaborate with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to address any discrepancies or concerns identified during the review process. Act as the SME for the QC function, providing guidance and expertise on quality control best practices, methodologies, and regulatory requirements. Lead and support the development and implementation of QC processes, procedures, and standards to ensure consistent quality across all pharmaceutical development activities. Provide technical support and training to QC personnel and other stakeholders on QC principles, techniques, and regulatory expectations. Ensure all reviewed and approved documents comply with applicable regulatory requirements, including FDA, EMA, ICH, and other global standards. Stay current with changes in regulatory requirements and industry best practices, ensuring that study protocols and reports are updated accordingly. Support regulatory submissions by providing QC-related documentation and expertise as required. Work closely with CMOs Quality Control units to ensure that all testing activities are conducted in accordance with approved protocols and regulatory standards. Investigate and resolve any deviations to testing protocols that occur at CMOs, ensuring a thorough understanding of the root cause and the implementation of corrective and preventive actions (CAPA). Monitor and follow up on the effectiveness of CAPA implemented by CMOs to ensure continuous compliance and quality improvement. Identify opportunities for process improvements in the QC review and approval process, and implement changes to enhance efficiency and effectiveness. Participate in internal audits and contribute to the development and refinement of standard operating procedures (SOPs) related to QC activities. Lead or support quality improvement initiatives, including root cause analysis and the implementation of corrective and preventive actions (CAPA). Ensure the integrity of all QC data by implementing robust data management practices, including proper documentation, storage, and retrieval processes. Review and approve QC data generated during pharmaceutical development studies, ensuring that it meets the required standards for accuracy, precision, and reliability. Support the implementation and maintenance of electronic systems (e.g., LIMS) used for QC data management. Work closely with cross-functional teams to ensure alignment on quality expectations and requirements for pharmaceutical development projects. Communicate effectively with internal and external stakeholders, including providing clear and concise feedback on study protocols and reports. Represent the QC function in meetings, discussions, and decision-making processes related to pharmaceutical development. Develop and deliver training programs for QC personnel and other relevant staff on quality control standards, procedures, and regulatory requirements. Mentor and support the professional development of QC team members, fostering a culture of continuous learning and improvement. Preferred candidate profile 5-8 years of experience in quality control within the pharmaceutical industry. Proven experience in reviewing and approving pharmaceutical development study protocols and reports. Strong understanding of regulatory requirements for pharmaceutical development and QC (e.g., FDA, EMA, ICH guidelines). Experience working with CMOs and managing deviations in a QC context. Interested Candidates can share your updated CV's to talent@difgen.com

Role & responsibilities - Handling of Stability Sample - Preparation of Protocol and report of stability - To ensure that the stability study shall be carried out as per stability calendar - Handling Retain sample - Temperature monitoring of stability and control sample room - Handling QMS Activity - Audit Handling - Document Review - QC, ADL and F&D. Preferred candidate profile: - Handling of QA Stability and Retain Sample Perks and benefits