Role & responsibilities Work on lead generation. Participate of RFIs, RFQs, and RFPs of new leads. Preparation of proposals. Preparation of Work Order. Preparation of change order. Preparation of Bid Defense Presentation Monthly SOP Compliance Checklist Preparation of Handoff and PIN Update list of activities. Preferred candidate profile . Candidate must be Postgraduate, preferably Life Science . Must have good communication skills . Should have good knowledge of PowerPoint and MS Excel Note- Interested candidates can share their CV at renuka.malhotra@jssresearch.com
Role & responsibilities Lead Generation & Prospecting Client Relationship Management Proposal & Bid Coordination Market Research & Strategy Support Sales Target Achievement Industry Networking & Events Participation Cross-Functional Team Coordination CRM & Documentation Management Preferred candidate profile Candidate must be Postgraduate, preferably Life Science Must have good communication skills Should have good knowledge of PowerPoint and MS Excel
Position: Project Manager Clinical Trials Company: JSS Medical Research Location: Chennai Work Mode: Hybrid Job Description We are inviting applications for the role of Project Manager for clinical trials conducted PAN India. Key Responsibilities Lead and manage end-to-end clinical trial projects across India. Coordinate with internal teams, trial sites, and sponsors. Ensure project deliverables are met within timelines and budgets. Oversee site performance and address operational challenges. Provide leadership and guidance to Clinical Research Associates (CRAs). Maintain comprehensive and compliant study documentation. Preferred Candidate Profile Minimum 2 years of experience as a Project Manager in clinical trials. Must have experience in team handling. Sound knowledge of ICH-GCP and Indian regulatory guidelines. Excellent communication, leadership, and team coordination skills. Interested candidates may send their updated resume to renuka.malhotra@jssresearch.com with the subject line: Application for Project Manager Clinical Trials .
Role & responsibilities Prepare Study Specific Quality Control Plan Perform ongoing QC for specific projects. Perform check testing for the database. Perform final inspection of the database. Perform Lab Data QC Perform QC of Randomization Envelopes Perform IWRS testing Prepare reports for all the activities. To coordinate with internal and external auditors for Quality Assurance Any other duties as assigned by supervisor or department. Knowledge of: MS Office Requirements of Good Clinical Practices Requirements of Good Documentation Practices Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records Basic knowledge of clinical research
Role & responsibilities- Prepare and update the Annotation list, Data Validation Plan, Edit check Specifications, and Database /Data Entry Screens as per study requirements. Preparation of Operational manual (EDC Trials) Preparation of CRF Filling Guidelines. Perform query management as per the study requirements including the manual queries raised by the data entry team and medical coder, query generation, and resolution. Quality check form updates and re-verification. Filling the data in 2 CRF(s) or database testing. Validate the external data after uploading it into the database. SAE and Lab data reconciliation. Update self-evident correction queries in self-evident correction form per study requirements. Update reports and trackers regularly or as per study requirements. Any other duties as assigned by the supervisor or department. Skills and Qualifications- Knowledge of: MS Office Requirements of Good Clinical Practices Requirements of Good Documentation Practices Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records
Requirements: - BDS, BHMS, BAMS, Diploma in Data Management, Bachelor of Physiotherapy. - OR Certificate/Diploma in Clinical Data Management (CDM). - Strong attention to detail and organizational skills. - Good understanding of GCP and clinical trial workflows is a plus. - Basic knowledge of Microsoft Excel and Word.
Role & responsibilities To perform data entry per allocated CRFs with minimal errors. To enter the Laboratory data in the database To perform Database Screen testing Raise the Data Entry Alert Forms (DEAFs) Signature & date the front sheet of the CRFs Any other duties as assigned by supervisor or department Preferred candidate profile Skills and Qualifications: Knowledge of: MS Office Requirements of Good Clinical Practices Requirements of Good Documentation Practices Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records Good typing speed with accuracy Ability to: Work in a team Managing work within timelines Experience and Education: Preferably science graduate with knowledge of clinical trials with good typing speed.
Role & responsibilities Handle Data Management Projects independently as Project Lead and responsible for timely completion of all activities as defined in the Scope of Work. Coordination with internal and external teams including Sponsors for various activities of the project. Meet customer requirements as per Scope of Work and ensures compliance to protocol, applicable regulatory guidelines and SOPs. Preparation and review of various project related data management documents and project reports. Provide project related trainings to project team and optimum resource utilization. Development and Review of SOPs. Tracking the status of all study activities. Serving as the primary contact with sponsor / CRO / Lab / Vendor for Data Management Activities. Provide required trainings to Data Management Teams Any other duties as assigned by superior in department. Preferred candidate profile Skills and Qualifications: Knowledge of: MS Office Requirements of Good Clinical Practices Requirements of Good Documentation Practices Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records Basic knowledge of clinical research Ability to: Work in a team. Managing work within timelines Take discission Experience and Education: BDS/BAMS/BHMS/ Bachelors in any discipline Masters in any branch of science or pharmaceuticals Diploma in Clinical Research Minimum 2 Years of Experience in Data Management handling end-to-end projects.
Role & responsibilities Assist in preparing Notices, Agenda, and Minutes for Board Meetings and General Meetings. Help in maintaining Statutory Registers as required under the Companies Act, 2013. Support in filing various forms on the MCA portal (DIR-3 KYC, MGT-7, AOC-4, CHG forms, etc.). Assist in KYC updates of Directors and bank account documentation . Help in preparing and compiling documents for Annual Return and Annual Filing . Assist in ensuring compliance with RBI guidelines and other statutory authorities. Support in updating Authorized Signatories in banks. Provide assistance in routine secretarial tasks and departmental activities. Any other work assigned by the Head Finance time to time. Preferred candidate profile CS Executive or CS Professional . Good understanding of Companies Act, 2013 and MCA filings. Strong communication and drafting skills. Attention to detail and willingness to learn. Proficiency in MS Office.
Essential Functions: The following duties represent the principle job duties however they are not all inclusive: Physically check the IPs on receipt from Sponsor/ dispatched to the sites Safe storage of IPs to maintain their potency and shelf life as per sponsor guidelines. Proper stock maintenance. Reconciliation of IP/ Device Coordinate IP / Device destruction as per Sponsor requirement Verification of all pharmacy instruments and Equipments to ensure their proper working conditions & is kept clean and kept in good working order Maintenance of Temperature and Humidity conditions in Pharmacy Storage area Preparation, Attendance and FU of internal / Sponsor audits. Primary point of contact with sponsor / site/ JSS for all IP related issues. Coordination with the courier for seamless operations. To operate efficient stock control appropriate to the needs of the trial with the objective of ensuring continuity of supply for subjects and minimizing wastage through out-of-date stock & in ensuring proper inventory control systems including, control and monitoring of stocks, introduction of new study IPs, removal of non-moving and expired stock. To ensure that shelves and all work surfaces are regularly cleaned to maintain a high level of hygiene within the pharmacy. To take prompt action in response to any IP alert bulletins that may be received from time to time. Implementing the SOPs An inquiring approach towards customer & client care. Any other duties as assigned by the supervisor in the department. Skills and Qualifications B. Pharm/ M. Pharm/ Postgraduate- Lifesciences MS Office Requirements of Good Clinical Practices Requirements of Good Documentation Practices Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records
Role & responsibilities Physically check the IPs on receipt from Sponsor/ dispatched to the sites Safe storage of IPs to maintain their potency and shelf life as per sponsor guidelines. Proper stock maintenance. Reconciliation of IP/ Device Coordinate IP / Device destruction as per Sponsor requirement Verification of all pharmacy instruments and Equipments to ensure their proper working conditions & is kept clean and kept in good working order Maintenance of Temperature and Humidity conditions in Pharmacy Storage area Preparation, Attendance and FU of internal / Sponsor audits. Primary point of contact with sponsor / site/ JSS for all IP related issues. Coordination with the courier for seamless operations. To operate efficient stock control appropriate to the needs of the trial with the objective of ensuring continuity of supply for subjects and minimizing wastage through out-of-date stock & in ensuring proper inventory control systems including, control and monitoring of stocks, introduction of new study IPs, removal of non-moving and expired stock. To ensure that shelves and all work surfaces are regularly cleaned to maintain a high level of hygiene within the pharmacy. To take prompt action in response to any IP alert bulletins that may be received from time to time. Implementing the SOPs An inquiring approach towards customer & client care. Any other duties as assigned by the supervisor in the department. Preferred candidate profile 3 Years experience B. Pharm/ M. Pharm/ Postgraduate- Lifesciences MS Office Requirements of Good Clinical Practices Requirements of Good Documentation Practices Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records
Role & responsibilities Handle minimum 2 projects per month (may vary as needed). Act as SPOC for clients for assigned and junior writers projects. Attend client meetings and coordinate with internal teams. Deliver high-quality documents and incorporate feedback. Review and mentor Junior Medical Writers; provide training and guidance. Ensure adherence to all applicable SOPs and participate in trainings. Support Senior Medical Writers in annual SOP updates . Preferred candidate profile Degree in Life Sciences/Pharmacy/Medicine. Relevant 56 years of medical writing experience. Strong communication, quality focus, and project management skills.
Company Description JSS Medical Research is a full-service clinical research organization (CRO) with extensive operations across the globe. The organization has a strong reputation for its methodological expertise in designing and conducting clinical studies for all phases of development, including Phase I, II, III, and post-approval studies. JSS Medical Research is committed to partnering with clients throughout the entire product lifecycle to ensure successful outcomes. The organization is also recognized for its strong academic affiliations and continuous contributions to the industry through publications, webinars, and thought leadership. Role Description This is a full-time remote role for a Regulatory Medical Writer. The Regulatory Medical Writer will be responsible for drafting, reviewing, and finalizing regulatory documents such as clinical study reports, investigator brochures, and other essential documents. Responsibilities include performing literature reviews, adhering to regulatory guidelines, collaborating with cross-functional teams, and ensuring the accuracy and quality of scientific communication. The ideal candidate will work closely with stakeholders to meet project deadlines and regulatory compliance standards. Qualifications Proficiency in medical and scientific writing, familiarity with regulatory document preparation, and the ability to interpret clinical and scientific data. Strong understanding of clinical study designs, statistical principles, and regulatory guidelines such as ICH-GCP and FDA/EMA standards. Excellent organizational skills, attention to detail, and the ability to meet tight deadlines. Strong collaboration and communication skills with experience working in cross-functional teams. Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and other relevant tools. Advanced degree in life sciences, pharmacy, or a related scientific field; PhD or equivalent is considered an asset. Previous experience in a similar role in the pharmaceutical, biotechnology, or clinical research industry is highly desirable.