Established in the year 2000 as a Biocon subsidiary, Clinigene became India's first CAP (College of American Pathologists) accredited Central Laboratory. Clinigene's services now span a broad spectrum of activities including human pharmacology, bioanalytical research, central laboratory, clinical operations, medical writing, medical monitoring, safety management, pharmacovigilance, clinical data management & biostatistics and regulatory services supporting early-phase through late-phase clinical development programs. We have extensive working knowledge of a wide range of products such as biologics, biotechnology products, vaccines, devices and small molecules. All activities are carried out in strict compliance with regulatory and ICH GCP requirements.
Post:
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Manager - Clinical Operations { See Below }
Position: Manager - Clinical Operations
Job Description:
*Overall responsible for day to day activities of Clinical Operations.
*To be involved in designing and planning of clinical trials.
*To liaise with financial management of proposed and ongoing projects.
*Conduct feasibility studies for proposed clinical trials.
*Finalize the selection of sites and investigators.
*Provide clinical operations input to study protocol.
*Review recruitment strategies and timelines.
*Identify training needs and formalize training plan for clinical operation personnel.
*Identify areas of work within the department for new recruits.
*Prepare training program /schedule for the year.
*Check Clinical Trial Research SOPs and finalize list of SOPs provided by external sponsor.
*Quality System Management for relevant SOPs.
*Handling of the study proposals.
*Up gradation of site infrastructure.
*Coordinate with the legal department to finalize all relevant agreements and contacts necessary during the conduct of clinical trials.
*Arrange for Clinical Trial Liability Insurance.
Candidate Profile:
*Candidate should have strong leadership skills, strong verbal, written and interpersonal communication skills and knowledge of project management.
*Should be responsible for the development and implementation of clinical research processes and systems.
Additional Information:
Qualification:Post graduate in life science / B.D.S / MBBS / MD / M. Pharmacy / B. Pharmacy
Experience: 8 - 10 years.
No. of Position: 2
Location: Bangalore
FORWARD YOUR CV TO: careers@clinigeneintl.com
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Position: Project Manager – Clinical Operations
Job Description:
*Will assist in the feasibility analysis and identification, recruitment and selection of investigators.
*Select on-board and orient the team that will be assigned to a project in league with the Manager and Head, Clinical Operations.
*Plan the conduct of the clinical trial and assist in developing trial management systems.
*Assist the Manager in planning the project, in order to accomplish its goals or produce the required results within constraints such as time, cost and agreed quality standards
*Assist the Feasibility and Proposal team in the preparation of study budgets
*Plan investigator meetings in league with the sponsor, and present information at these meetings
*Decide the management of recruitment strategies
*Decide in liaison with the Senior CRAs, the management and preparation of tracking documents
*Decide the management of the study drug supply/equipment delivery, shipment, inventory, and accountability
*Create documents required by the project team prior to the start of the study (e.g. protocols, feasibility questionnaires, confidentiality disclosure agreements, etc.)
*Assist in site selection in league with the Feasibility and Proposal team and the Sponsors
*Overlook the conduct of site evaluation and initiation visits by the CRA-II/Senior CRAs and review and approve the visit reports within the stipulated timelines.
Candidate Profile:
The Project Manager supports the Manager, Clinical Operations, and oversees all aspects of the project using planned, monitored and controlled processes, and is ultimately responsible for the co-ordination and completion of the project. The Project Manager may be responsible for more than one project at a time. The Project Manager will serve as a mentor to all the members in the study team that he/she is responsible for.
Additional Information:
Qualification:Post graduate in life science / B.D.S / MBBS / MD / M. Pharmacy / B. Pharmacy.
Experience: 5 - 8 years.
No. of Position: 3
Location: Bangalore
FORWARD YOUR CV TO: careers@clinigeneintl.com
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Position: Clinical Research Associate
Job Description:
*Assist Project Manager with feasibility analysis and identification, and selection of investigators.
*Assist Project Manager in planning the conduct of the clinical trial and developing trial management systems.
*Assist in preparation of study budgets.
*Prepare documents for ethics committee and regulatory submissions.
*Assist in the planning and coordination of investigator meetings and prepare presentation materials and present information at these meetings.
*Assist in the management of recruitment strategies, when necessary.
*Assist in the management and preparation of tracking documents.
*Assist Project Manager with management of study drug/supply/equipment delivery, shipment, inventory, and accountability.
*Create documents required by the project team prior to the start of the study (e.g. protocols, feasibility questionnaires, patient tracking tools, etc.).
*Prepare, plan, organize and conduct pre-study (site selection) visits and report on these visits to Project Manager to assist in site selection.
*Prepare, plan, organize and conduct site initiation visits.
*Collect and review essential documents from study sites.
Candidate Profile:
The Senior CRA monitors projects under minimal supervision, supports the Project Manager and provides input to the feasibility, planning, investigator selection, budgeting, logistics, conduct and reporting of the study. The Senior CRA may be called on to serve as a mentor to junior CRAs and/or to undertake special projects or roles relating to project management.
Additional Information:
Qualification:Post graduate in life science / B.D.S / MBBS / M. Pharmacy / B. Pharmacy.
Experience: 2 - 4 years.
No. of Position: 4
Location: Bangalore
FORWARD YOUR CV TO: careers@clinigeneintl.com
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Position: Junior Executive
Job Description:
*Handle business development for BA/BE studies.
*Conduct market research.
*Represent Clinigene in national and international trade shows.
*Handle techno commercial activities like preparation of proposals, promotional materials, and execution of agreements.
*Liaise with technical team and clients for execution of BA/BE studies.
*Handle client engagements including client visits
*Develop business plan
Desired Profile :
*Candidate should have a basic knowledge of ICH-GCP/GLP/ICMR and other national and international regulations for BA/BE studies.
*Should have thorough understanding of BA/BE business with willingness to learn new techniques/regulations.
*Should have good interpersonal and communication skills.
*Should be conversant with various business communication tools including MS applications, audio-/video conference tools.
Additional Information:
Qualification: Graduate / Post graduate in pharmacy or medicine with or without MBA.
Experience: 4 - 6 years.
No. of Position:1
Location: Bangalore
FORWARD YOUR CV TO: careers@clinigeneintl.com
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Position: Project Physician
Job Description:
*Prepare and review clinical study documents like protocol, Investigator brochure, informed consent forms, patient dairies etc.
*Handle medical queries.
*Support feasibility team in the assessment of the feasibility of a project.
*Handle safety reports
*Train CRAs in different therapeutic areas.
Desired Profile :
*Should have working knowledge of various accepts of clinical trials including the medical, regulatory and operational aspects like ICH GCP, Schedule Y, Biostatistics, etc.
*Should have good academic background especially the medical training.
*Must have working knowledge of MS Office tools like Word, Excel, Power point, etc.
*Should have experience in medical writing (publication if any).
*Should have the ability to analyze and infer information especially medical, preclinical, and pharmaceutical.
*Should be able to prepare medical manuscript for various purposes.
Additional Information:
Qualification: MD, Pharmacology /Phd Biology
Experience: 0- 1 years
No. of Position:1
Location: Bangalore
FORWARD YOUR CV TO: careers@clinigeneintl.com
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