Pharma Recruitment at National Institute of Malaria Research - Consultant Post

The ICMR-National Institute of Malaria Research Dwarka, New Delhi has initiated a joint project with The Infectious Diseases Data Observatory , Oxford University for the capacity building of young researchers. This Project aims to train young researchers and provides a valuable opportunity for two-way capacity building and for maximising the rapid application of results to inform policy in India. This approach will help reduce the gap in collaboration for secondary use of data and create new possibilities of capacity building and knowledge creation.

Project : An IDDO-ICMR joint project for capacity building of young researchers

Consultant Scientific (Medical/ Non-Medical)
No. of Vacancies : 07 Posts
Essential Qualification & Minimum Experience required
Professional with M.D. (Microbiology / Community Medicine) with experience in infectious/vector-borne diseases OR Ph.D. (Medical Pharmacology / Medical
Microbiology / Public health / Life Sciences) from recognized Institution
Desirable
• Knowledge or research experience in medicine, biology, parasitology, epidemiology or surveillance of infectious diseases - specifically in eliminable vector-borne diseases
• Experience of successful contribution to a multidisciplinary team.
• Experience of biostatistical application in the field of medical statistics and/or epidemiology.
• Experience of conducting and analysing biomedical research and clinical trials especially with large and diverse datasets.
• Proven administrative and/or project management skills, including attention to detail and the ability to keep accurate tracking records.
• Knowledge or previous experience with data sharing and data management.
• Experience in supervision of research teams, students or other staff members.
Age : Upto 45 years

Nature of Duties
Scientific Support:
• Contribute to the development of scientific research initiatives and strategies to build international data sharing frameworks and scientific collaborations for PRIDs.
• Engage with external researchers and other key stakeholders to coordinate, develop and disseminate research activities including meta-analyses of data held in the IDDO repository. This process includes participation in the writing and preparation of grant reports, scientific reports and manuscripts for publication and their submission for publication.
• Support the writing and editing of other key documents including study protocols, ethics applications and project summaries & briefs.
• Perform literature reviews and maintain an updated literature database (including latest publications, trials, etc.).
• Work closely with other researchers to support the development of statistical analysis plans (SAPs) and support the statistical analyses of research activities.
Participate in Programme Management activities, including:
• Working in collaboration with IDDO Programme Managers to manage current or proposed PRID data platform activities, including coordinating the activities and timely achievement of milestones.
• Provide operational and secretarial support to disease specific committees overseeing agreed deliverables.
• Participate in the production of monthly/quarterly reports of platform activities as required.
• Contribute to the preparation of annual/final reports.
Participate in Stakeholder Engagement, Communication and Advocacy activities, including:
• Work closely with project partners to promote disease specific activities/outputs locally and internationally.
• Maintain close communication, and high-quality interactions with key stakeholders e.g., research scientists, policy makers and funding bodies.
• Present ICMR activities and findings at international scientific meetings.
• Participate in capacity strengthening activities provided by partner institutions.
• Support preparations for conferences, meetings and events including contributing to publications, abstracts, posters, presentations and related material, both electronic and in printed format.
• Additional duties as delegated and appropriate for the grade.

Consolidated Emoluments : INR 80,000/- per month
Tenure : One year
Place of work : ICMR-National Institute of Malaria Research, Dwarka, New Delhi

Consultant - Clinical Research Manager (CRM)
Age : 45 years
Essential Qualification & Minimum Experience required
• MBBS or MD in Pharmacology/Medicine/Paediatrics and relevant experience of clinical trials conduct or Ph. D. in Medical Pharmacology/MedicalMicrobiology/Life Sciences) from recognized Institution
• ICH-GCP training
• At least 06 years’ experience post MBBS in clinical R&D and ICH-GCP guidelines OR at least 04 years’ experience post MD/post PhDin clinical R&D and ICH-GCP guidelines
• At least two years of clinical trial management experience in India and /or Asia Pacific region
• Demonstrated proficiency in the implementation, monitoring, and management of clinical trials
• Experience of working in the public and private sectors is highly desirable
• Experience and understanding of issues related to antimalarial drug resistance and therapeutic efficacy studies would be an advantage

Nature of Duties
Coordination of the clinical trials conducted by NIMR in India and, if needed, other Asian countries
• Day to day management and/or oversight of clinical research associate(s) involved in the studies, including review of monitoring reports, identification and resolution of issues identified during the monitoring visits
• Provide backup, support and advice/mentorship for trial monitors including co-monitoring and substitute monitoring as and when required
• Contribute to safety reporting activities e.g. Serious Adverse Events (SAE) reporting including with sites, ethics and regulatory agency as specified by safety management plan and periodic safety reporting plan.
• Ensure coordination of local monitoring and data management activities and provide support to the trial data management team including Trial Statistician and Data Managers
• Interacts with Medical, Biostatistics and R&D teams on sample and data analysis to maintain compliance, GCP, data protection and ethical requirements
• Assist with the coordination of data review with cross functional team to support database lock
• Manages team quality issues with investigational sites and/or vendors
• Liaise with IDDO, WWARN and all other trial partners for trial related activities and payments
• Support and respond to requests from trial/study site team members and PIs on trial/study related matters
• Arrange trial/study specific and applicable training for trial/study site teams and identify training needs for collaborative sites.
• Management of local vendors: i.e. local courier and local labs
Development of clinical trial capability
• Support site identification, assessment, and development of capability to support existing and new clinical projects and studies.
• Provide clinical operation expertise for the planning and set-up of Indian clinical trial sites and laboratory networks for new projects and studies.
Ensure regulatory compliance for projects
• Be familiar with drug development regulatory requirements, documentation and processes for regulatory authorities (FDA/EMA) and have thorough knowledge of Indian regulations (Schedule Y) and of the clinical development process.
• Ensure projects follow GCP and applicable regulatory requirements and maintain appropriate documentation
• Preparation and submission of all regulatory documentation required for the study on behalf of NIMR and assist with relevant documentation for study sites.
• Review clinical SOPs and other standard documents required for clinical trials
• Contribute to the set up and to review of NIMR/IDDO systems related to clinical operations as appropriate.

Manage and develop project reporting systems
• Develop project schedules with the Project Leader and the Project Team
• Monitor milestones for project evaluation with the project team
• Interact with study site teams on a regular basis to ensure that projects achieve set milestones
• Collect data and information to enable the Project Lead to make effective and cost-efficient use of NIMR/IDDO resources
• Provide logistical support and tracking for all trial resources/materials with the trial monitors, trial managers and site investigators
• Liaise with the project consultants and collaborators within the project network
Support for NIMR/IDDO Project team
• Play a full role in the NIMR/IDDO partnership and to be an active member of the project team working in India and abroad
• Under supervision of the Project leader be able to represent NIMR/IDDO to the relevant medical authorities (Ministries of Health and drug regulatory authorities) as and when needed
• Under supervision of the Project leader be able to represent NIMR/IDDO in India, in both scientific and communication events as and when needed
• Help to build long term relationships with key research centres and individual investigators to support NIMR/IDDO objectives and presence in India

Consolidated Emoluments : INR 1,00,000.00 per month
Tenure : One year
Place of work : ICMR-National Institute of Malaria Research

PROCEDURE FOR RECRUITMENT:
1) Candidates meeting the age criteria and possessing the required qualifications, experience, etc. can send duly application form along with updated CV by email at nimriddo@gmail.comup to 05:00 PM on 23rdApril 2021.
2) The shortlisted candidates will be informed regarding interview at NIMR, Delhi via email or telephonically.
3) Candidates have to submit the duly self-attested copies of proof of their age, educational qualifications, experiences, testimonials etc. at the time of joining, if selected.
4) Selected candidates have to bring all the documents as mentioned above in Original while joining. KINDLY NOTE: The shortlisted candidates will be informed through e-mail about interview. Other terms and conditions for applications are given here under: 1) Incomplete applications or not submitted in prescribed format or without photo and signature or received after last date shall be summarily rejected. 2) Submission of incorrect or false information shall disqualify the candidature at any stage 3) Since the posts are purely on temporary basis, no benefit of Provident Fund, Leave Travel Concession, Medical, etc. will be available to the appointee
4) Age limit and experience will be considered as on the date of receipt of Application Form.
5) The Director, NIMR has the right to accept/reject any application without assigning any reason thereof and no correspondence will be entertained in this matter.
6) The Director, NIMR reserves the right to increase/decrease the number of vacancies as per requirement.
7) The Director, NIMR reserves right to fill up or not fill up any of the post advertised on website.
8) Canvassing and bringing outside influence in any form for short listing or employment will be treated as disqualification and the candidate will be debarred from selection process.

9) Any addendum/corrigendum in respect of above vacancy notice shall be issued on the NIMR website www.nimr.org.in and no separate notification shall be issued in the print media. Applicants are requested to regularly visit the website: nimr.org.in so to keep them updated
10) Qualification and experience should be in relevant discipline/field and from a reputed institution/organization recognized by relevant authority.
11) Mere fulfilling the essential qualification/experience does not guarantee selection.
12) The postis contractual for the duration offered. The appointment may be renewed after every specific period of time subject to satisfactory performance and project requirement.
13) The post is filled-up on purely temporary basis and contractual basis & the candidate will have no right to claim for any type of Permanent Employment under ICMR-NIMR or continuation of his/her services in any other project.
17) The reserve panel candidate will be valid for one year.