Global Project Management Cliantha Research

1.0 - 2.0 years

2 - 3 Lacs

Ahmedabad

Work from Office

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)

Posted 2 weeks ago

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Quality Assurance Cliantha Research

4.0 - 6.0 years

3 - 5 Lacs

Ahmedabad

Work from Office

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.

Posted 3 weeks ago

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Pharmacokinetics Scientist Cliantha Research

0.0 - 4.0 years

3 - 5 Lacs

Ahmedabad

Work from Office

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

Posted 1 month ago

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Costing and Proposal Associate- North America Cliantha Research

2 - 7 years

5 - 7 Lacs

Ahmedabad

Remote

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

Posted 2 months ago

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Clinical Investigator NAVITAS LIFE SCIENCES

- 2 years

6 - 9 Lacs

Mangaluru

Work from Office

Roles and Responsibilities Responsible for screening volunteers for clinical study and to decide the eligibility of a subject based on detailed history, physical examination, radiological and electrocardiograph and laboratory parameters. Monitoring, Reporting and Management of Adverse Events/ Serious Adverse Events occurring during clinical study Determination of Volunteer eligibility for Clinical Study as per Inclusion/exclusion criteria of protocol. Maintenance of Emergency Drugs List and ICU set-up. Maintain records of screening procedures as per GCP and other applicable regulatory requirements. Co-ordinate with respective CI/PI/Head in all study related activities. Perform any other activities as and when assigned by the management Desired Candidate Profile Qualification: MBBS with Medical Council registration Job Location: Mangalore - Karnataka (Office based)

Posted 2 months ago

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