Role & responsibilities : Help drive department transformation programs which may include implementing risk based auditing approaches, streamlining processes and documentation, implementing data analytics & continuous audit, improving indicators & performance metrics, developing audit training & development, enhancing stakeholder & Audit Committee reporting and department budgeting processes Support connectivity set up including VDI provisioning, trouble shooting and continuous improvement of these processes to ensure the best IT end user experience Implements a change process into the project lifecycle, implementing and controlling processes to manage change requests Design and document processes and procedures for application development Work with QA to determine technical solutions enabling IT engagements to ensure regulatory and enterprise function compliance (risk, privacy, information security and business continuity) Preferred candidate profile: Required Skills & Experience: Windows AD and Group policy Implementation and Troubleshooting Implement and troubleshoot Virtualization (VMware, Nutanix) Hand on experience on Citrix VDI, server Load balancing and server and SAN storage implementation and Troubleshooting Good Communication and documentation skills

Requirements for Candidature: Basic Knowledge for BABE and Clinical Research, Good Communication Skills, Analytical Thinking, Basic Knowledge of Computer and MS Office Preferred Candidate Profile B.Pharm / M.Sc / M.Pharm. Freshers

MD/MV Roles and Responsibilities:- MD/MV group does assay method development and validation for various drug and their metabolites in biological fluids like plasma serum or urine by using LC/MS/MS. During method validation precision, accuracy, stability of drug/metabolite in biological fluid as well as after extraction is evaluated. The validated methods are then followed for the analysis of subject samples analysis for doing bioequivalence study.

Role & responsibilities: A. Responsible for development and guidance to Business Development, Marketing, Project management and Proposal teams about sponsor requirements. B. Identify, evaluate, and prioritize potential clients (existing and new) for targeted business development activities and responsible for promoting the services offered by Cliantha research Ltd across the Globe. C. Responsible for representing the company at various conferences and platforms for business development activities. D. Responsible for early phase development sales of the company against the target assigned during the financial year. E. Responsible for guiding the proposal team against the activity assigned and closing the deals as and when required. F. Responsible for guiding the Marketing team for periodic update to clients. Preferred candidate profile: We are looking for a candidate from Pharmaceutical/Clinical Research Organization Industry with relevant 8-10 years of experience in to business development. Interested candidates can share the resume on recruitment1@cliantha.com This opportunity is not for medical representatives & core field sales candidates.

Role & responsibilities Clinical Data Manager To co-ordinate with the respective Study Lead of the CDM department to ensure effective study progress and support the Study Lead in departmental functions and activities at Cliantha Research. A. Create, maintain and update study specific documents like Data Management Plan, Creation of Data Validation Plan, database design specifications, external data handling plan and other study specific documents. B. Designing Case Report Forms for paper and EDC studies and reviewing CRFs design. C. Receipt and tracking of subject CRFs (for paper based CRF studies). D. Co-ordinate with other study team members for data management related tasks on study activity. E. Perform UAT in study database based on the edit checks created. F. Check consistency of Data Entry screens with case report form. G. Train the clinical sites on using the study specific database for Electronic Data Capture (EDC) studies and process role-specific database access as per request received. H. Identify and resolve data discrepancies in clinical data via computerized and manual data checks. I. Perform data management QC for assigned study. J. Generate queries, Update and Verify the received DCFs and Ex-DCFs (for paper based CRF studies). K. Handle the external data and perform the applicable external data reconciliation process and resolve queries pertaining to the external data. L. Perform Serious Adverse Event (SAE) Reconciliation and resolve queries pertaining to the SAEs. M. Perform Medical Coding of terms reported on Case Report Form. N. Be compliant with Standard Operating Procedure, work procedures and project scope of the work and ensure quality. O. Maintain documentation of training as appropriate. P. Work with other members of the project team. This includes but is not limited to External team, Programmer, Statistician, Monitor and CRA. Q. Conforms to training schedule for self, maintains awareness of SOP content in the Data Management team, according to company requirements. R. Ensure appropriate archival of project data and documents is carried out as per the applicable Archival SOP.

Role & responsibilities: A. Responsible for conduct of various medical tasks during conduct of clinical study as delegated by Investigator B. Conduct clinical examination of all subjects participating in clinical Studies C. ICF presentation to volunteers and answer queries D. Monitor vitals and subject well being during the study E. Handle Adverse events, their documentation and follow-up F. Assist investigator with other assigned duties as training and experience allow G. To assist in the accurate compilation of raw data II GENERAL CLINICAL DUTIES: A. Screening of subjects. B. Training of the clinical staff on practical aspects, after applicable experience C. Maintain a database of contractual medical staff Preferred candidate profile: MBBS/MD(Pharmacology)

Role & responsibilities:- Nursing care Monitoring of vital signs ECG conduction Documentation in CRF Check in activity Dosing activity Sampling activity Sample processing activity's Preferred candidate profile:- Candidate must have nursing registration (GNM) Only female candidates are preferred.

MD/MV group does assay method development and validation for various drug and their metabolites in biological fluids like plasma serum or urine by using LC/MS/MS. During method validation precision, accuracy, stability of drug/metabolite in biological fluid as well as after extraction is evaluated. The validated methods are then followed for the analysis of subject samples analysis for doing bioequivalence study. Candidates must experience in MD-MV onto LC/MS/MS for drugs and their metabolites in various biological fluids. Well versed in operating and trouble shooting LC/MS/MS instruments. Well versed in literature search, basic computer knowledge and MS-office. Aware of recent trends in regulated bioanalysis and regulatory guidelines Perform the extraction of samples using wet chemistry. Centrifuges, evaporators, freeze specimens as required. Performs aliquots of samples for wet chemistry. Performs wet chemistry according to study protocol guidelines and/or SOPs. Completes QC sheets and makes log book entries as required by protocol and/or SOP. Operate HPLC, LC/MS/MS and ICP-OES; troubleshoots problems and performs minor repairs

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.

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)