Clinical Research AssociateResponsible for planning, initiation and monitoring of clinical trials to international GCP standards throughout Asia. The successful candidate must have the following:
· A Master Degree or equivalent in Medical, Scientific or Nursing discipline
· 2 to 4 years of clinical trial experience is required
· Availability to travel frequently throughout Asia
· Excellent attention to detail
· Strong communication skills and computer literacy
Email Resume: kbs@kbsconsultants.comClinical Trial AssistantResponsible for assisting Senior Clinical Research Associate/Clinical Research Associate for planning, initiation and monitoring of clinical trials to international GCP standards throughout Asia. The successful candidate must have the following:
· A Master Degree or equivalent in Medical, Scientific or Nursing discipline
· 1 to 2 years of clinical trial experience is required
· Excellent attention to detail
· Strong communication skills and computer literacy
Email Resume: kbs@kbsconsultants.com JOBS, SAS Clinical Trials Project Manager, Clinical Research Associate, CRA, Statistical SAS Programmer jobs, Employment, Career, Relocation, programmers, developers,Healthcare, pharma, clinical research, clinical trials, sas programmers,Clinical Trials Project Manager
Our clients based in Australia require Seebeyond Consultants with experience in HL7
Seebeyond Experience in ICAN 5.0
Experience of working in healthcare Sector with HL 7 Standard
Apart from that good J2EE experience and background, atleast 4-5 years experience.
Good communication Skills Email Resume: kbs@kbsconsultants.com
Project Manager Clinical Research
Qualifications & Experience
Phd/MSc in Life sciences or pharmacy with 5-7 years of clinical researchexperience
Job Description and Responsiblities
Handling complete Project Management for assigned projects, tracking project budget, Ensuring compliance to SOPs/Protocols/ICH GCP/local and International Regulations, Training of CRAs and Investigators, ensuring quality and speed for assigned projects, preparing for inspections and audits. Any other duties assigned from time to time Email Resume: kbs@kbsconsultants.com
CRA - Clinical research Associate (Experienced)
Qualifications & Experience
Msc/BSc in Life science or pharmacy with 1-3 years of clinical research experience
Job Description and Responsiblities
Handling all clinical trial related acctivities, right from Identification of sites, organising Investigators' Meetings to study start,monitoring and study close-out activities. Ensuring appropriate storage and Inventory Management of trial supplies. Comply with SOPs/Protocols/ICH GCP/local and International Regulations, Training of Investigators and Team, ensuring quality and speed for assigned projects, preparing for inspections and audits. Any other duties assigned from time to time. Email Resume: kbs@kbsconsultants.com
Medical Writer
Qualifications & Experience
Msc in Life Sciences/MBBS 1-3 years of clinical research experience and exposure too Medical Writing.
Job Description and Responsiblities
It is important for the medical writer to have a broad understanding of the statistical theory in evidence-based medicine, without necessarily following all the mathematical calculations. Preparation of clinical protocols, investigator brochures, monitoring plans, patient and study site education materials, clinical program newsletters and clinical study reports. Preparation of annotated bibliographies and literature reviews, manuscript preparation from source data; editing and review of physician-prepared manuscripts; editing and quality-assurance of manuscripts, format posters, meeting handouts, presentation compendia. Development of in-house clinical monitor training programs and curricula; therapeutic area monitor training materials, CME educational brochures, slide kits, and training materials with the help of Project Managers Email Resume: kbs@kbsconsultants.com
Quality Analyst - Clinical Trial Quality
Qualifications & Experience
Phd/MSc in Life sciences or pharmacy with 5-7 years of experience in Clinical Trial Quality Department Email Resume: kbs@kbsconsultants.com
Clinical Pharmacologist
Qualifications & Experience
MD Pharmacology Email Resume: kbs@kbsconsultants.com
Analyst Bioanalytical Lab
Qualifications & Experience
M Pharm/MSc in Analytical Chemistry with 0-1 years in Bioanalytical Lab
Job Description and Responsiblities
Performing bioanalytical work including method development, validation and sample analysis as per the protocol in compliance with GLP. Maintaining instrument logbooks. Performing equipment troubleshooting (in case of malfunctions), periodic calibration and maintaining relevant records in coordination with maintenance department. Sample tracking (receipt, check, storage, shipment, disposal) and maintaining records theirof. Daily monitoring and recording of temperature, humidity and pressure in laboratory. To ensure cleanliness and neatness in the laboratory with the help of laboratory assistance. Maintenance of records/logbooks for water analysis, periodic checks of safety related aspects like fire extinguisher, first-aid box, eyewash etc. Email Resume: kbs@kbsconsultants.com
Bioanalytical Executive
Qualifications & Experience
M Pharm/MSc in Analytical Chemistry with 1-3 years Experience in Bioanalytical Lab
Job Description and Responsiblities
Responsible for all matters related to Bioanalysis in-line with GLP requirements and periodic review of SOPs. Development of protocols, co-ordination with the Scientific Manager/Head-BR for protocol approval. Conducting bioanalytical activities (development, validation and sample analysis) as per approved protocol. Maintenance of bioanalytical records and relevant logbooks. Planning and supervision of study requirements. Supervising day-to-day activities conducted by analyst in the laboratory and guiding/training the analysts. Procurement and maintenance of reference standards, reagents, analytical columns etc. Ensuring calibration and maintenance of equipments (HPLC, LC-MS/ MS etc). Email Resume: kbs@kbsconsultants.com
Scientific Manager
Qualifications & Experience
Ph.D./M.Sc. in Analytical Chemistry /M. Pharm. with 3-5 years experience
Job Description and Responsiblities
To supervise day-to-day operation and personnel performing different functions in the laboratory with respect to Bioanalytical projects. Training the personnel in Laboratory. Review of data and reports. Co-ordination with Clinical, Regulatory and Data Management and Administration departments for execution of projects. Liaison with clients whenever necessary. Implementation of systems adhering to GLP requirements in coordination with QA. Review of method development and validation protocols, method validation reports and Bioanalytical reports. To prepare for internal and/or external audits. To review and approve of Standard Testing procedures (STP). Email Resume: kbs@kbsconsultants.com
Phlebotomists
Qualifications & Experience
DMLT
Job Description and Responsiblities
Canula insertion & removal, blood collection, monitoring of subjects for AE, dosing, CRF completion, maintining of ICU equipments, Email Resume: kbs@kbsconsultants.com
Custodian Pharmacology
Job Description and Responsiblities
Graduate with 1-2 Years of experience in a Human Pharmacology Unit volunteer coordination, physical check, monitoring of volunteers during study, check in process, check out process Email Resume: kbs@kbsconsultants.com
Medical Officer & Duty doctor
Qualifications & Experience
MD/MBBS in general medicine
Job Description and Responsiblities
perform physical check, ECG, X-ray, coordinate with central lab for results, dosing of medication, safety analysis and AE monitoring Email Resume: kbs@kbsconsultants.com
DMLT Technicians
Qualified DMLT Technicians with relevant skills and experience Email Resume: kbs@kbsconsultants.com
Clinical Data entry operators
Job Description and Responsiblities
Data entry operators with Life sciences(Bsc, Msc, B.Pharm etc) back ground and clinical data entry experience
Clinical / medical data entry, query initiation Email Resume: kbs@kbsconsultants.com
Quality - Data capture
Qualifications & Experience
Experienced CDM quality supervisors with life sciences background
Job Description and Responsiblities
Assuring 100% quality of captured data, query resolution, initiating and managing the quality system for a CDM unit Email Resume: kbs@kbsconsultants.com
Project co-ordinator CDM projects
Experienced in co-ordinating CDM projects
Job Description and Responsiblities
CRF tracking and general project management. Interface with client co-ordinators as required. Proposal preparation and payments management Email Resume: kbs@kbsconsultants.com
Medical coding
Job Description and Responsiblities
Experienced in medical coding using WHO ART, MEDRA etc.,
Medical coding for AE's, SAE's, medicines etc Email Resume: kbs@kbsconsultants.com
Hardware engineer Clinical Data Management related IT systems
Job Description and Responsiblities
IT to provide with specs Maintainance of complete hardware and delivering 100% up-time of all CDM related IT systems Email Resume: kbs@kbsconsultants.com
Software programmer Clinical Reports
Job Description and Responsiblities
General programming specific to databases, with workable knowledge of PageMaker, front page, other computer applications etc., Database creation, maintainance, front end design, CRF design, DB security, cleaning, closing and other s/w activities related to CDM etc., Email Resume: kbs@kbsconsultants.com
Report Executives Reporting clinical statistical
Qualifications & Experience
People with Life sciences(Bsc, Msc, B.Pharm, Medical etc) back ground and clinical report writing experience
Job Description and Responsiblities
Writing reports statistical, medical, proposals, regulatory etc., Email Resume: kbs@kbsconsultants.com
Documentation Librarian
Job Description and Responsiblities
Preparing, reviewing, all quality, process, systems related documents. Initiating, maintaining, updating etc of the complete CDM documentation including SOP's and managing related library function (10%) Email Resume: kbs@kbsconsultants.com
Clinical Data Manager
Qualifications & Experience
M Pharm/BPharm/Life sciences Graduates with Experience in Clinical Data management
Job Description and Responsiblities
Manage, Co-ordinate, motivate and deliver the CDM objectives of clean data on time including project management Email Resume: kbs@kbsconsultants.com
Biostatistician
Qualifications & Experience
PhD/ MSc in Statistics with specialisation in Biostastics with experience in working with drug discovery and development teams
Job Description and Responsiblities
Statistical planning, analysing, review, reporting, quality checking of data received etc., Email Resume: kbs@kbsconsultants.com
Biostatistics Manager
Qualifications & Experience
PhD/ MSc in Statistics with specialisation in Biostastics with experience(5-8 yrs) in working with drug discovery and development teams
Job Description and Responsiblities
Manage, Co-ordinate, motivate and deliver the Biostatistics team's objectives of statistical reports on time including project management Email Resume: kbs@kbsconsultants.com
Support staff Clinical research data management
Job Description and Responsiblities
Assist in various documentation activities (preparation of report/records, coordination with printer procurement of stationary and office requirements). To call for quotations, compare the quotation for the best available prices and release the purchase order for the items required. Tracking of inventory (logistics). Email Resume: kbs@kbsconsultants.com
JOB DESCRIPTION
Position Title: Business Development MANAGER
Department: Business Development – Clinical Research
Reports To: COO - Clinigene
Primary Position Purpose Summary
Oversees the contract development and approval, proposal development, change order management and clinical project feasibility processes within Business Development. Provides sales training to BD staff and provides strategic BD support to sales team as it relates to eServices initiatives. Serves as point person for strategic alliances with technology partners. Supports BD staff with creative solutions, coordination, input and dispute resolution.
Primary Job Responsibilities
1. Manages and trains members of the BD staff
2. Provides oversight for development and quality of all proposals
3. Provides oversight for contract and change order development, negotiation and approval
4. Provides oversight for patient recruiting (e.g., MMG) and technology (e.g., PHT) alliances
5. Facilitates development of clinical feasibility process and associated incorporation into proposals
6. Tracks all proposals, contracts, change orders and other BD documentation
7. Participates in the planning and execution of company sales activities
8. All other projects as assigned
Key Skills (list 3-5 skills required to perform job successfully):
1. Excellent communication skills (interpersonal, written, verbal, formal presentation)
2. Experienced negotiation skills
3. The ability to work with and manage people
4. Ability to perform overnight business travel, up to 50%
5. Excellent persuasive/selling skills
Experience:
1. Minimum of seven years sales experience, at least three of which are in the CRO industry
2. Minimum of three years management experience and at least one year of P/L responsibility
3. Demonstrated understanding of Phase I through Phase IV drug development
Education (degree) or Certifications:
1. Advanced degree in an appropriate scientific or business discipline (doctoral degree or MBA degree preferred)
Email Resume: kbs@kbsconsultants.com
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KBS consultants
Flat H,Kulothungan Apts,No, 5 Natesan Road
Ashoknagar, Chennai 600 083 India
Phone: +91-44 2489 5341 / 2371 9622
email:kbs@kbsconsultants.com
