Karmic Current Vacancies
1. CRA I & II
Educational Qualification: M.Sc. in Clinical Research / Post Graduate Diploma in Clinical Research
Experience: 3-6 Years
Manage end-to-end monitoring activities for Phase I-IV clinical trials conducted by Karmic right from Site Initiation to Site Monitoring and Close-out, ensure timely reporting in terms of monitoring reports, follow-up letters, safety reports etc. and ensure study conduct in line with Protocol Requirements, ICH-GCP Guidelines, Regulatory Guidelines, SOPs and Sponsor brief. Conduct Site Initiation Visits (SIV), conduct Protocol, ICH-GCP and SOP training at sites, demonstrate study procedures including Source Templates Filing, Annotated CRFs & CRF filling instructions (Paper/EDC), Informed Consent procedures, Patient Screening & Eligibility procedures, IP Handling procedures, Safety Reporting & Unblinding procedures etc. to investigators and CRCs, ensure timely SIV reporting & follow-up letters. Conduct routine Site Monitoring Visits (SMV) to clinical sites, do Source Doc Verification, review Site Master Files (SMFs), relevant study and patient records, resolve open site issues, ensure timely SMV reporting and follow-up letters
Interested candidates please e-mail your CV to hr@karmiclifesciences.com
2. Project Manager – Clinical Operations
Educational Qualification: M.Sc. in Clinical Research / Post Graduate Diploma in Clinical Research
Experience: 5-8 Years
Coordinate end-to-end project activities for assigned Phase I-IV clinical projects right from Project Team Selection and Training, Partner Qualification and Selection (SMO’s, Central / Local Labs, Translation Vendors, IP Storage / IVRS Vendors, Centralized ECG / Radiology Vendors, Logistics Vendors etc.), Study Budgets and Timeline Planning, Site Initiation, Investigator Screening, Recruitment and Training, Patient Recruitment Oversight, Study Monitoring and Study Close-out Oversight, Weekly & Monthly Project Tracking, SLA Management and Reporting activities. Meet with clinical investigators and their staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff, confirm the appropriateness of the IRB/EC and ensure that all documentation required to initiate the study is complete. Negotiate study budgets and any other contractual agreements with sites/investigators and vendors. Plan or assist in conducting Study Start-up Training and Investigator Meetings. Monitor study progress to assure compliance with Protocol Requirements, ICH-GCP, Indian DCGI, US FDA / EMEA and other applicable guidelines and laid down Karmic/Sponsor SOPs. Monitor and track all project metrics including patient enrolment rates, study timelines and study budgets as per project plan, provide weekly reporting to and attend sponsor telecons
Interested candidates please e-mail your CV to hr@karmiclifesciences.com
3. Project Manager – Clinical Data Management
Educational Qualification: Masters in any Life Sciences Discipline / Masters in Information Technology / Masters in Clinical Research
Experience: 4-7 Years
Manage end-to-end clinical data management projects (Paper / EDC) at Karmic. Provide oversight to all project activities right from Project Planning, Project Team Set-up, Training, Receiving and Reconciling CRFs to Database Design on CDMS (Clintrial 4.6) / EDC (kClinion EDC / OC RDC / Other Systems), Database Testing & Release, Data Entry/Verification, Discrepancy Management, SAE Reconciliation, Medical Coding, Quality Assurance, Database Lock and Data Extraction, DMF Maintenance etc. Build systems, procedures and SOPs in line with 21 CFR Part 11, CDISC and ICH-GCP compliance, implement a fully integrated quality assurance program in the DM function to ensure achievement of all project metrics including planned accuracy, productivity and reporting timelines. Provide oversight to DM Team Leads/Data Managers and support in the development of Data Management Plan, Quality Plan, User Requirement Specifications and Functional Specifications documents for study design and edit check programming and on other CDM/Functional issues including Data Discrepancy Management, SAE Reconciliation, Database Lock/Unlock, Site & Query Reporting, Project Metrics Reporting etc.
Interested candidates please e-mail your CV to hr@karmiclifesciences.com
4. Senior Medical Writer
Educational Qualification: MD/MBBS/BAMS/BHMS/M.Pharm/PhD (preferably in pharmaceutical sciences)/M.Sc in Life sciences or Biological sciences, with knowledge of clinical research.
Experience: 3-8 Years
Liaise with sponsor and co-ordinate meetings to initiate document preparation, manage multiple projects across therapeutic areas, provide intellectual inputs to team for document preparation, mentor team members in all aspects of medical writing, perform quality check of activities performed by team members, develop and maintain necessary templates, formats and style to ensure that the documents generated meets industry, institutional and client requirements, to ensure that deliverables adhere to agreed timelines. Design and develop Protocol Synopsis, Protocols, CRF’s, ICF’s, IB’s, Study Reports, Safety narratives and Medical Manuscripts for clinical studies under overall guidance of Head, Medical and Safety Writing.
Interested candidates please e-mail your CV to hr@karmiclifesciences.com
5. Senior SAS Programmer
Educational Qualification: M.Sc. Statistics
Experience: 4-8 Years
To act as the overall oversight for Statistical Programming Team at Karmic and review and approve all statistical programming activities right from Statistical Analysis Plan (SAP) and Tables Figures and Listings (TFL) design to Randomization Schedule Generation, Sample Size Estimation, Statistical Programming and Validation, Interim Analysis and Final Analysis and Statistical Analysis Report (SAR) as per ICH-E9 standards. Support global benchmarking and application of standards such as CDISC, SDTM, AdaM etc. to statistical programming activities and work on creation of global SAS macros and libraries to enhance efficiency of SAS programming activities
Interested candidates please e-mail your CV to hr@karmiclifesciences.com
6. Business Development Associate
Educational Qualification: BBA in Sales/Marketing, B.B.M., B.Com, B.Sc., B.E.
Experience: 1-2 Years
To manage business development, sales and marketing activities for Karmic across designated geographies/target segments and to ensure achievement of planned short term and long term sales revenues and profits. Assist the BD Head/Managers in driving aggressive sales and revenue growth in all geographies and client segments of choice and ensure meeting planned sales numbers. Research and build databases of target clients across specific geographies and market segments, establish first level communication with client through cold calling, email campaigns, one-on-one meetings under the BD Manager’s supervision etc. Generate leads and build a solid sales pipeline for the company in all areas of focus including Clinical Data Management, Clinical Trial Management, Regulatory Consulting, and Bio-Analytical, Pre-Clinical etc.
Interested candidates please e-mail your CV to hr@karmiclifesciences.com
7. Head – Global Business Development (US Based Position)
Educational Qualification: MBA in Sales/Marketing, MD, MBBS
Experience: 8-15 Years, 6-8 years in front end sales with Pharma/CRO
Senior Sales Profile to be based in the US with direct reporting to the Chief Executive Officer and Board of Directors of the company. Responsible for $ 8-10 Mn+ annual targets and oversight of 3-4 key global sales staff located in US/Europe. Handle strategic sales and pipeline build-up, market segmentation, targeting, penetration and closure of $ 2 Mn+ global CRO deals, competitor tracking, sales planning including global annual revenue and P&L targets and key customer relationships. Should have atleast 6-8 years of direct CRO sales experience with impeccable closure track-record and highly polished communication skills with experience handling C level executives at large to mid-sized pharma accounts and a strong personal network of key industry contacts.
Interested candidates please e-mail your CV to nidhi.saxena@karmiclifesciences.com
If you feel you may fit in for any alternate role not provided above, please write to us alongwith your CV at hr@karmiclifesciences.com
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If you are PASSIONATE about SCIENCE, INQUISITIVE about TECHNOLOGY, have FIRE in the BELLY, are STREET SMART and ENTREPRENEURIAL and want to MAKE a DIFFERENCE, join KARMIC and get KARMIKIZED!!
We are India’s fastest growing CRO that has grown by over 400% last year and working with us is no less thrilling than flying a Kamikaze or being chased by a speeding torpedo. With a highly empowering and entrepreneurial culture, creative chaos and disruptive innovation, focus on large goals and larger aspirations, lot of seat of pants learning and minimal hierarchies, we seek to create India’s dominant CRO. And it is not all sweat but a lot of fun on the way with high-tempo parties, adventure offsites, pool and table tennis challenge competitions and a little Yoga thrown in just in case you want to calm down.
