Job Title: Sr. QA Associate / QA Associate Clinical Trials Location: Mumbai Education: B.Pharm / M.Pharm / M.Sc. / B.Sc. / Life Sciences Job Description: We are looking for a proactive and detail-oriented Sr. QA Associate / QA Associate to join our Quality Assurance team for Clinical Trials. The ideal candidate will be responsible for ensuring GCP compliance across clinical trial activities, conducting internal and external audits, and supporting regulatory inspections in alignment with ICH-GCP, applicable regulatory requirements, and sponsor expectations. Key Responsibilities: Perform internal audits (e.g., system, process, and study-specific audits). Conduct vendor audits (e.g., clinical sites, laboratories, and service providers). Review and approve SOPs, protocols, CRFs, ICFs, and other essential trial documents. Ensure compliance with ICH-GCP, CDSCO, US FDA, EMA, and other applicable guidelines. Track and manage deviations, CAPAs, and non-conformance reports. Participate in inspection readiness activities and support sponsor/regulatory audits. Maintain QA metrics and dashboards for quality tracking and reporting. Provide GCP training to internal teams and vendor staff, as needed. Collaborate with cross-functional teams (Clinical, Regulatory, Data Management, etc.). Ensure timely escalation and resolution of quality issues. Desired Candidate Profile: 2 to 6 years of QA experience in Clinical Research, preferably in a CRO environment. In-depth knowledge of GCP, ICH guidelines, and applicable local/global regulations. Experience in conducting clinical trial audits (sites, systems, vendors). Strong verbal and written communication skills. Detail-oriented, analytical, and able to manage multiple projects simultaneously. Preferred Skills: Experience in handling sponsor or regulatory audits (e.g., USFDA, EMA). Familiarity with electronic QMS or eTMF systems. Certification in GCP or Quality Assurance will be an added advantage.
MAIN OBJECTIVE OF THE JOB:- The Sr. Project Manager assumes responsibility for an individual project, or many projects. As he/she is the liaison with the sponsor, the project manager communicates in an optimal way, making sure that specific sponsor objectives are met. The function of the Project Manager involves little or no people management and focuses completely on the product development programme and trials. JOB RESPONSIBILITES:- Expert theoretical and practical knowledge of ICH-GXPs requirements applicable to Clinical Operations and ability to train others in all those guidelines. Expert knowledge of and compliance with relevant international and local regulatory requirements. Conversant with and completely equipped to handle all activities as listed below but not limited to Accurate identification of SAEs (if applicable), with appropriate follow up action and documentation Identifies potential study problems, implements solutions, follows through to resolution and improves timelines. Proper and timely escalation of issues. Demonstrates ability to assist Associate Director and team with projecting timelines and achieve project deliverables. Demonstrate ability to assist Associate Director by contributing in Co-Monitoring & detailed review and/or finalization of trip visit reports and follow-up letters within timelines as delegated by Associate Director. Assist Associate Director in keeping track of trip visit frequency and its timely reporting by tracking monitor’s schedule per project monitoring plan (if applicable) on on-going basis. Demonstrate proficiency in conducting all visit types, including accompanied visits for training/mentoring purposes. Excellent communication skills, including effective and appropriate interaction with the study team, site staff, other KLINERA departments, senior management (director level and above) and any external parties involved (sponsors, vendors and other third parties). Ability to facilitate team building, conflict resolution and negotiation as needed to promote productivity and the accomplishment of timelines. Ensure quality maintenance of study related files (both electronically and hardcopy) Successfully handle complex issues, including appropriate prioritization of competing tasks/assignments for self and team members with minimal input from manager Excellent training and mentoring skills (including constructive feedback) Active participation in client meetings/teleconferences/general communications. Ability to participate in bid defence meetings if applicable. Development of high quality study-related documents, including, but not limited to, study-specific processes, newsletters, team training materials, and study status reports for client meetings Understanding the management of unit based contracts and profitable staff utilization/recovery according to the units within the contract for clinical services Provides effective and timely feedback to the CRA team as appropriate Effective negotiation of (or oversight of) Investigator site contracts and budgets, where applicable Actively participates in site payment runs and basic understanding regarding data input into tracking systems and analysis of site payments with supervision Participate in the hiring Clinical Operations personnel interview process and provide feedback as requested. Initiates Risk and Contingency Plans before risks arise and implements plans/triggers appropriately Demonstrate the ability to manage multi-service and/or cross-functional medium to large/complex projects in accordance with timelines and budgets. Demonstrate expertise to prepare and handle audits (both internal/ external/ sponsor) &/or inspection and follow through till CAPA resolution.) Has demonstrated ability to train/coach CRA team on all types of visits. Ensures designated study team consistently meets the quality standards and metrics requirements for well written trip reports and follow-up letters Competency in supervising the set up/maintenance of the study files to audit standards. Successfully handle complex issues, including appropriate prioritization of competing tasks/assignments for self and team members Good training and mentoring skills (including constructive feedback) to team members and the ability and willingness to mentor less experienced CRA/ Sr. CRA/ CTL/ APM/ CPM – as applicable, if required. Demonstrates thorough knowledge of tracking systems including analysis of data output for potential errors and study trends. Effectively manages staff through open, timely and regular feedback. Ensures individual and team achievements are appropriately recognized. Participates in the hiring process while recruiting Clinical operation Personnel and provide feedback. Ensures staff turnover is minimal by supporting staff recruitment and retention initiatives, as required. Participates in local, departmental and company initiatives/activities. Remain aligned to common organization objectives and individual project deliverables. Flexible to take up add-on responsibilities & deliver satisfactorily all the tasks assigned by respective functional manager/ Associate Director&/or H-GCO in order to support the project deliverables &/or department improvisation. Demonstrate and maintain customer focus REQUIRED EDUCATION:- A graduate or post-graduate with science &/or medical &/or pharmaceutical back ground. Diploma &/or degree in Clinical Research. Industry accreditations for Clinical Project Management experience &/or equivalent role. REQUIRED EXPERIENCE:- Approximately total 10-12+ yrs. of industry experience either in CRO/Sponsor companies with minimum hands –on experience of 2-4 years as CTL/Asst. PM/ CPM. Fundamental knowledge and good understanding of GCP, clinical study development process, and logistics. Great and consistent attention to detail and follow through on commitments. Ability to manage and lead the project team. Previous line as well as functional management experience will be an added advantage. REQUIRED SKILL SETS:- Ability to make decisions involving conflicts of interest Appoint and divide tasks giving clear instructions Coordination and planning of budgets, people and time management Problem solving at a strategic level, working with others to reach a resolution Careful planning to achieve accurate and timely results Open and clear communicator Work well under pressure ensuring tasks are prioritized and goals are met OTHER REQUIREMENTS:- Ability to take up 30-50% of travel – both national and international to meet business needs. Easily accessible and approachable to meet project &/or organization deliverables.