Roles & Responsibility: Perform method development, method validation and study sample analysis under supervision of Project Manager (s). Passaging of cells as well as performing cell based assays while maintaining aseptic conditions in cell culture laboratory. Perform ELISA & other Ligand Binding Assay according to study protocol guidelines and/or SOPs Processing of specimens to support the clinical studies. Preparation of required reagents and solvents. Preparation of SOP(s) and work instruction. Following GLP, GDP, GCLP & other good practices. Desirable candidate: MSc BioTech/ Biochemistry/ Microbiology or BTech Biotech fresher. 0-1 year of relevant experience will be preferable. Sound knowledge on Immunology. Good communication skills, analytical skills and team coordination.
We are looking for a candidate for Costing & Proposal- North America in Cliantha Research Limited. Job timing: 05:00 PM to 02:00 AM Job location : Remote Job Description: Preparation and completion of all RFPs upon request and assignment. Analyze quotes and cost sheets/templates and optimize where applicable. Preparation and completion of Work orders / Change Order requests. Use business analytical skills to seek efficiencies in cost containment. Work with and communicate across multiple levels of business and stakeholder organizations to determine how to improve existing business processes. Performs all work in accordance with established departmental processes, regulatory requirements, while working in compliance with safety standards Experience Required: 3 years of CRO / pharmaceutical or equivalent business experience preferred Excellent business writing, communication, editing and proofreading skills Ability to meet stated deadlines Ability to work independently and collaboratively as required Strong analytical and problem solving skills, with demonstrated ability to plan, multi-task and prioritize, with a strong process background Proficient in spreadsheet and database applications Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively Excellent interpersonal skills and ability to relate well to internal and external customers Strong written and verbal communication skills Ability to make effective decisions in a timely manner Strong technical proficiency and computer skills in all aspects of MS Windows and MS Office software packages Interested Candidates can share the resume on recruitment1@cliantha.com
Role & responsibilities : Work as Pharmacokinetic and Scientific Affairs Personnel. 1. Provide feasibility inputs like study design, sample size estimation, sampling time points, wash out period, etc. 2. Review, evaluation and interpretation of PK/PD data from BA/BE studies-clinical trials and suggesting appropriate inputs in protocol and clinical study report 3. Review statistical report as per requirement. 4 Prepare and review statistical/pharmacokinetic analysis plan as per requirement 5. Archive and retrieval of data 6. Maintain and update feasibility database as per requirements 7. Maintain and assist regulatory query handling and tracking. 8. Provide impact assessment of PK related protocol deviations/Con-med assessment Preferred candidate profile: M. Pharma with min.1-2 years of relevant experience as PK Scientist in Clinical research (BA/BE studies). Job Location: Ahmedabad
IT PRINCIPAL DUTIES AND RESPONSIBILITIES: Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of tasks to which the employee may be assigned. - STUDY RELATED ACTIVITIES : A. Initiates, maintains, and revises applicable IT procedures, software operations, software validations and documentation to mitigate IT risks against data integrity requirements. B. Develops/implements corrective action plans for resolution of problematic IT compliance issues to meet with the user IT requirements. C. Handling and management of routine electronic data backup, electronic data archiving and electronic data including backend database, instrumental data and other file formats. D. Conduct IT specific audits for various activities like vendor qualifications, departmental process/systems, documentation etc. - GENERAL DUTIES: A. Work with concerned user departments to understand their requirements/issues to provide support by implementing systems, procedures, and policies to comply with regulatory expectations with IT compliance. B. Documentation and record maintenance for relevant/applicable IT compliance processes. C. Prepare reports for head/management and external regulatory bodies as and when required. D. Reporting to Sr. Manager Compliance IT for IT compliance related activities and provides reports on a regular basis for requirement and progress of compliance efforts. - ADMINISTRATIVE DUTIES: A. Confirms to training schedule for own position and maintains awareness of SOP content, according to company requirements. B. Maintain awareness of recent trends and advances for IT processes.
Job Location: Ahmedabad Job Role for Biostatistician: 1. Provide inputs regarding sample size, study design, randomization and PK-statistical analysis in protocol. 2. Prepare randomization schedule using SAS for the project as per the protocol. 3. Perform and review statistical analysis of pharmacokinetic pharmacodynamic parameters using phoenix WinNonlin or SAS. 4. Prepare summary and final reports for the study. 5. Perform the validation of the SAS codes and softwares used for calculation and analysis of Pharmacokinetic and statistical data. 6. Maintain all necessary records for the reporting phase of the study. 7. Prepare inputs in sample analysis detail Preferred Candidate: M.Sc(Statistics) fresher candidate with basic understanding of BA/BE.
Role & responsibilities: Sample collection, dosing, separation
BASIC SKILLS AND ABILITIES REQUIRED Demonstrate ability to pipette accurately. Knowledge of all basic of ELISA, instrumentation such as centrifuge, vortexer, shaker, Milli Q water system, Analytical Balance, freezer, refrigerator, water bath, volumetric flask, microplate washer, microplate reader and other lab related activities etc. Also demonstrate ability of handling biological samples, reagents as well as working/reference standards. MINIMUM EDUCATION, TRAINING AND EXPERIENCE REQUIRED A minimum of B.Sc or equivalent education unless demonstrated competence through work experience. SUPERVISED BY Project Manager SUPERVISES None. PRINCIPAL DUTIES AND RESPONSIBILITES Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of tasks to which the employee may be assigned. I RESPONSIBILITES A. Responsible as sample handling person for activities like recipient and storage of study samples, blank matrices and bulk spiked samples. Also will be responsible for labeling, retrieval, restorage, retention, shipment and disposal of study samples and bulk spiked samples as required and for the relevant documentation of sample handling activities. B. All activities related to reference standard, volumetric flask, analytical balance, centrifuge, vortexer, shaker, Milli Q water system, freezer, refrigerator, pipette, microplate washer, microplate reader etc. along with their maintenance record. C. To ensure the availability of first aid box and proper functioning of safety equipments in laboratory. D. Preparation of In-house ??Certificate of Analysis¢? for working/Reference standards. E. Issuance and recipient of Working/Reference standards. F. Maintenance of temperature monitoring devices. G. Maintain inventory of laboratory equipment spares. H. Assess and ensure adequate recourses are in place. I. Coordinate with lab personnel for smooth functioning of day to day lab activities. J. To supervise the glassware cleaning activity and laboratory store.
Experience: 2-4year experience in the clinical research in a quality control. Role & responsibilities 1) Review of clinical raw data as per predefined Quality Control Plan for completeness, accuracy, and for compliance with the Study Protocol, GCP, SOPs and applicable regulatory Guidelines. 2) Online Monitoring of study activities to ensure that studies are conducted in accordance with GCP, SOPs, Protocol and applicable regulatory guidelines. 3) Issuance, Reconciliation and Accountability of Controlled forms/ Documents as per applicable SOP. 4) Preparation of projects for QA audit and Archiving. 5) Review of Tabular listing appended to Clinical Study Report and Individual Subject CRF scan check (as applicable). 6) Assist QC in-charge in review of Quality Control- Clinic SOPs. 7) Any additional responsibility given by Head of the Department / Management 8) Perform source data verification (SDV) activity (as sponsor requirement) 9) Review the safety Lab data (as per Data Transfer Agreement) Job Location: Vadodara (Gujarat)
Job Location: Noida (On-site) JOB SUMMARY: Responsible for coordination of assigned clinical trial related activities along with Principal investigator/ Clinic In-Charge / Director Clinical Operations, Sub-Investigator. Responsible for Handling of investigational products, trial related documentation, performing trial activities with other study personnel, communication with the sponsor, ethics committee, inter and intra departments. Carry out responsibilities in accordance with the organizations policies, procedures. Maintain knowledge of and follow all relevant Cliantha Research SOPs. Familiar with concept, practices and procedures of specified field. Preferred Candidates: Minimum one year of relevant experience in project coordination in Clinical research. Excellent English communication
Role & responsibilities:- Nursing care Monitoring of vital signs ECG conduction Documentation in CRF Check in activity Dosing activity Job timing: Rotational shift (Day & Night) Job location: Vadodara Preferred candidate profile:- Candidate must have nursing registration Only Male candidates are preferred.
Job location: Ahmedabad Experience Required- 4+ years of experience in QA (Clinical Research) Role & responsibilities A. Review Protocol and its attachments. B. Conduct in-process and retrospective audit of clinical phase of the study to ensure compliance to protocol, SOPs and applicable regulatory requirements. C. Review Clinical report to verify that the data reported in the report, accurately reflects the raw data and to ensure that the report is prepared in compliance with SOP, ICH E3 and applicable regulatory requirements. D. Conduct system audits as per the system audit plan. E. Conduct vendor pre-qualification and re-qualification audits as per the vendor audit plan. F. Preparation, Review, distribution, maintenance, recall and destruction of QMS Documents (SOPs, Policies, WIs, Manuals, forms and Plans . ) G. Review and maintain calibration, validation and Mapping documents and Temperature data / OOS data (Eurotherm data )review. H. Issuance of logbooks. I. Review of deviations, event and change control procedures and provide number to respective document. J. Provide Instrument IDs as per SOP. K. To maintain/update study/System specific tracker/Index on on-going basis. L. Assisting Team in charge in Regulatory/Sponsor Audit. M. Maintain Master Signature Log.
Role & responsibilities:- Nursing care Monitoring of vital signs ECG conduction Documentation in CRF Check in activity Dosing activity Job timing: Rotational shift (Day & Night) Job location: Ahmedabad Preferred candidate profile:- Candidate must have nursing registration
Role & responsibilities: Sample collection, dosing, separation Qualification : DMLT, MLT
JOB SUMMARY: Responsible for designing and preparation of Protocol, Case report form, Informed consent document and other protocol related documents in consultation with Group-In charge and Investigators, interdepartmental and intradepartmental communication, obtaining approval of protocols from the sponsor and Ethics Committee. A. Preparation of Protocols, Informed Consent Documents, Case Report Forms, and other protocol related documents as per applicable regulatory requirements in consultation with Group In-charge, Principal Investigator, Biostatistician, Analytical Investigator, and Head of the department. B. Coordination with study personnel and other departments for protocol related issues for finalization of protocol. C. Approval of protocols from Ethics committee in consultation with Principal Investigator and Sponsor. D. Translation of Gujarati Informed Consent Documents from English to Gujarati. E. Responsible for updating the protocol related concerns to investigator(s), sponsor and Ethics Committee. F. Preparation and revision of related SOPs. G. Conforms to training schedule for own position and maintains awareness of SOPs contents according to company requirements. H. Stays current with the ongoing changes in the pharmaceutical regulatory environment, i.e. FDA, GCPs, GLPs, etc. Job Location: Ahmedabad (On-Site)
Role & responsibilities: Responsible for creating, coordinating and maintaining the Master Study Schedule for all Cliantha sites. Working with all Head of Departments (HODs) of Cliantha Research on a regular basis to ensure the relevant project milestones are discussed and needs of Sponsor and functional areas are not compromised. Create, plan and monitor all project activities in PM database ensuring accuracy at all times. Responsible for identifying interdependencies for all projects and facilitate communication among functional areas where required. Understands time-sensitive nature of critical path project activities and notifies the relevant teams, and/or management of related issues. Works with management to establish project interim milestones and ensures projects are on schedule to ensure our report structure/compilation is communicated and assist where required, i.e. CS-BE , FDA tables Preferred candidate profile The candidate must have experience in BA/BE Studies with excellent English communication (Mandatory)
Study Analyst Roles and Responsibilities:- General extraction procedures and instrument analysis of drugs in biological fluids. STUDY RELATED ACTIVITIES:- A. Perform the extraction of samples using wet chemistry. B. Centrifuges, evaporators, freeze specimens as required. C. Performs aliquots of samples for wet chemistry. D. Performs wet chemistry according to study protocol guidelines and/or SOPs. E. Completes QC sheets and makes log book entries as required by protocol and/or SOP. F. Operate HPLC, LC/MS/MS and ICP-OES; troubleshoots problems and performs minor repairs. GENERAL LAB DUTIES:- A. Prepares required reagents and solvents. B. Under direction of the project manager, may perform some method development. ADMINISTRATIVE DUTIES:- A. Confirm to training schedule for own position and maintains awareness of SOP content, according to company requirements. Skills & Abilities:- Demonstrate ability to pipette accurately. Knowledge of all basic wet chemistry instrumentation such as centrifuge, vortex, pH meter, evaporator, etc.
Requirement: BASIC ACCOUNTING KNOWLEDGE WITH TDS AND GST COMPLIANCE, INVENTORY MANAGEMENT, SUPPORT ROLE OF CLINICAL TRIAL ACCOUNTING. Job Description: 1. Journal Entries: Post daily transactions such as expenses, revenues, and adjustments 2. Asset Management: Document and depreciate fixed assets; maintain asset registers 3. Compliance Support: Assist in preparing reports for tax and regulatory compliance (Including GST and TDS ). 4. Vendor Communication: Handle billing queries and resolve discrepancies with vendors 5. Audit Assistance: Support internal and external audits by providing necessary documentation 6. Bank Reconciliation: Match bank statements with company ledgers to identify discrepancies 7. Inventory Management : Physical Verification of Inventory Including yearend Valuation report 8. Import Payment : Import Payment (Services and Material )along with Submission of Form 15CA .
PRINCIPAL DUTIES AND RESPONSIBILITIES: Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of task to which the employee may be assigned. A. Co-ordinate with CDCs, database programmers and other study team members on study progress. B. Identify resource for the project and to manage resource needs to meet the study timelines. C. Creation and revision of standard operating procedure and study related documents. D. Get involved in study setup activities starting from protocol review, DMP creation, and review of eCRF design as per the protocol requirements. E. Conduct study setup meeting, delivering data management presentation at Investigator s meeting and to represent data management in various meetings with the sponsor. F. Provide training to project team as per the requirement and identify the training needs for the self and the team on ongoing basis. G. Ensure Creation and Maintenance of study binders and other appropriate study related documents until retention period. H. Provide inputs in defining database specifications, database design, validation programming and testing (UAT). I. Define the process of External Data handling, SAE Reconciliation and additional data review activities along with Head CDM. J. Ensure Export and transfer of datasets for statistical analysis as per requirement. K. Mentor the project team as and when required during the project life-cycle. L. Coordinate with the study team and communicate the important points to Head CDM. M. Ensure completion of all CDM activities before database close and lock. N. Tracking and managing the study, oversee study progress, identify risks and taking corrective action to rectify any errors in consultation with Head CDM. O. Coordinate with various functional areas such as clinical operations team, statisticians, medical writing team, clinical sites, central lab, other vendors, etc. for seamless project management. P. Keep the Head CDM informed about the project status in relation to quality and timelines. Q. Ensure quality on deliverables. R. Communicate and coordinate with QA team regarding the planned and completed audits, identify the repetitive errors, take necessary corrective action and preventive actions. S. Monitor metrics (productivity and quality). T. Participate in recruitment of new staff. U. Maintain documentation of training as appropriate. V. Develop, revise, coordinate, schedule and deliver effective training programs for designated staff members. W. Responsible for mentoring.
PROJECT RELATED ACTIVITIES: Responsible for creating, coordinating and maintaining the Master Study Schedule for all Cliantha sites. Working with all Head of Departments (HODs) of Cliantha Research on a regular basis to ensure the relevant project milestones are discussed and needs of Sponsor and functional areas are not compromised. Create, plan and monitor all project activities in PM database ensuring accuracy at all times. Responsible for identifying interdependencies for all projects and facilitate communication among functional areas where required. Understands time-sensitive nature of critical path project activities and notifies the relevant teams, and/or management of related issues. Works with management to establish project interim milestones and ensures projects are on schedule to ensure our report structure/compilation is communicated and assist where required, i.e. CS-BE , FDA tables Responsible for providing first level of support for all software problems reported regarding PM database and documenting problems and solutions as required. Solicit feedback from end users to ensure the database continues to meet the needs of the organization. Identify opportunities and recommend solutions that will enhance or improve current business processes. Provide basic training to end users on PM database, including cross-functional training. Maintain and keep current on a monthly basis all analytical methods and bioequivalence studies completed. Attend teleconferences as scheduled for projects and ensure effective communication of project milestones/activities. Demonstrates the ability to make complex interpretation and application decisions within role capacity by utilizing protocol, Standard Operating Procedures (SOPs) and/or other tools deemed appropriate. Provide summary reports to management as may be requested. Participates in on-going educational activities to enhance own knowledge level as well as that of other team members. Performs other duties as requested or assigned by department management, and/or Executives, as training experience allows. GENERAL DUTIES: A. Ability to effectively coordinate a number of projects simultaneously and manage multiple priorities. B. Ability to work well under pressure and work effectively in a constantly changing environment. C. Ability to work as a member of a team and contribute to the success of the projects. D. Recommends, develops and participates in the development or revision of internal procedures and standards with impact to department. E. Recognizes issues and takes appropriate corrective actions, consulting with appropriate staff as required. F. Fosters and maintains effective working relationships with all clients and functional units within Cliantha Research Ltd. ADMINISTRATIVE DUTIES: A. Conforms to training schedule for own position and maintains awareness of SOP content, according to company requirements. B. Stays current with the ongoing changes in the pharmaceutical regulatory environment, i.e. FDA, GCPs, GLPs, etc.
Role & responsibilities: Responsible for creating, coordinating and maintaining the Master Study Schedule for all Cliantha sites. Working with all Head of Departments (HODs) of Cliantha Research on a regular basis to ensure the relevant project milestones are discussed and needs of Sponsor and functional areas are not compromised. Create, plan and monitor all project activities in PM database ensuring accuracy at all times. Responsible for identifying interdependencies for all projects and facilitate communication among functional areas where required. Understands time-sensitive nature of critical path project activities and notifies the relevant teams, and/or management of related issues. Works with management to establish project interim milestones and ensures projects are on schedule to ensure our report structure/compilation is communicated and assist where required, i.e. CS-BE , FDA tables Preferred candidate profile The candidate must have experience in BA/BE Studies with excellent English communication (Mandatory) Job location: Ahmedabad