Clinical Data Manager in Novartis : B.Pharm

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A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Clinical Data Manager

Job Description: Provide timely and professional ongoing management of clinical trial data with respect to cost, quality and timelines for assigned trials managed within Clinical Data Management. Ensure consistently high quality data available for analysis and reporting.

1. As Clinical Data Manager (CDM) provide data management input on Clinical Trial Teams. May have the role of TDM on small, low complexity trials

2. Reviews and contributes to preparation of protocols, specifically related to the Visit Evaluation Schedule (VES), Study Design and Data Management section

3. Gives input to Data Handling Plan (DHP) and Data Review Plan (DRP) for assigned trials. Responsible for the development of these documents if assigned the role of Trial Data Manager (TDM)

4. Participates in the preparation of training materials for investigator meetings

5. Disseminates study-level information either to the TDM (if assigned to a trial as a Data Manager) or to the Clinical Trial Team (CTT) & Program Clinical Data Manager (PCDM) if assigned the role of TDM

6. Performs DM activities for start-up of a study including preparing the eCRF, CCGs, DHPs, DRPs and performing User Acceptance Testing (UAT) if required

7. Obtains input from study team members on the design of clinical databases while ensur-ing data quality and compliance with SOPs (if assigned the role of TDM)

8. Under supervision from PCDM (or delegate), ensures consistency of assigned trials with program level standards (DHPs, DRPs & eCRFs) Prepares final study documentation.

9. Performs ongoing review of all data generated from the clinical study including central and local lab data and coding

10. Interacts with the study team members to define the necessary listings needed to support data validation

11. Performs review of listings for quality, content, format and output

12. Identifies possible trends in data Leads and participates in the final review of all data generated from the clinical study

13. Participates in the preparation (if assigned as DM level) or prepare final study documentation

14. Performs final review of listings for quality, content, format and output

15. Performs activities necessary for database finalization and adhering to the timelines es-tablished by the study team

16. Verifies and tracks eCRF/CRF completion and provide data status updates

17. Ensures appropriate Novartis tracking systems are up to date and accurate

18. Actively participates at the study team level

19. Utilizes status and metric reports to identify training needs and issues with investigator sites

20. Gathers requirements for third party data

21. Maintains effective working relationships with Contract Research Organization (CRO) and other vendors as required

Candidate Profile: University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree Fluent English (oral and written). Ideally 3 years’ experience in Drug Development with at least 2 years in Clinical Data Management

Additional Information:

Location: Hyderabad

Industry Type: Pharma/ Biotech/Clinical Research

Functional Area: R&D

End Date: 25th January, 2016

Apply Here

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Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia

Vacancy in Drug resistant Breast Cancer project at NIN

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NIN has attained global recognition for its pioneering studies on various aspects of nutrition research, with special reference to protein energy malnutrition (PEM). Institute’s activities are broad-based, encompassing the whole area of food and nutrition. The Institute has achieved close integration in its research activities between the laboratory, the clinic and the community.

Name of the post/ position: Junior Research Fellow

Eligible candidates are invited to apply for the following post/ position on the ad hoc research project entitled: "Drug resistant Breast Cancer Cells to understand Cancer Stem Cells metabolism and therapy" funded by DBT at this Institute.

Applications will be received from the individuals on 5th January, 2016 between 9:30 A.M. and 10:30 A.M. at Conference Hall, NIN, Tarnaka, Hyderabad. Late applications will not be entertained after 10:30 A M under any circumstances. The Candidates may download Application form from NIN website.

The essential qualification, experience, consolidated Pay and service tenure are as under:

Essential Qualifications: Post Graduate Degree in Basic Science with NET qualification or Graduate Degree in Professional Course with NET qualification or Post Graduate Degree in Pharmacy from recognized University.

Desirable: Masters in Pharmacy or Bachelor in Pharmacy with GATE or GPAT exam qualifying score or M.Sc. in Biochemistry/ Biotechnology/ Life Science with NET qualifying score.

Age: Below 30 years. Relaxation of age is admissible as per G O.I. Rules.

Consolidated Stipend/ Emoluments: Rs. 12,000.00 + 30% HRA per month fixed without any other allowances.

Tenure: Initially for one year and extendable based on performance and funds position.

Date & Time of Written Test/ Interview: 5th January, 2016 from 9:30 A.M. onwards.

The shortlisted candidates should bring all original certificates of educational qualification (from SSC onwards), experience, SC/ST/OBC Community Certificate/ PH Certificates along with a pass port size photograph and set of Photo copies duly attested for attending the Written Test/ Interview. The persons belonging to Other Backward Category should bring the latest O.B.C. (Non-creamy layer) Certificate issued by the respective Tahsildar/ MRO specifically issued for the purpose of applying for Central Government Post. No TA/ DA will be paid for attending the Written Test/ Interview.

GENERAL CONDITIONS: The conditions of employment will be the same as that for the project staff on contract basis. The candidates have no right to claim for any regular employment at this Institute. The Director in-charge & Appointing Authority has the right to accept/ reject any application without assigning any reason/s and no correspondence in this matter will be entertained. Age, experience etc., will be reckoned as on 14 12.2015.

Selection Procedure: Written test/Interview will be conducted to the eligible candidates, if the large numbers of candidates are found to be eligible in the screening. If the lesser number of candidates are found to be eligible in the screening, interview will be conducted only to the eligible candidates for final selection. If written test is conducted, the names of the shortlisted candidates will be displayed on the Notice Board, which is kept in front of the Conference Hall on the same day.

Note: The applications will not be accepted by post/ courier.

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Happy Blogging...!!!

Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia

e­‐Learning in Public Health Management

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e-learning in Public Health Management (ePHM) course is the flagship course of e-learning at IPH. Started with the primary aim of capacity building of district and block programme managers in NRHM who largely come from management or non-public health background, this course was envisioned to introduce the target group to basic concepts of Indian public health system and also to train them in effectively managing the day to day activities of a district/ block health setup. This course was simultaneously also introduced to professionals who were not a part of the government health set up yet worked in close association with it.

Following two batches and several suggestions and inputs later, the consensus was that the level of the course though appropriate for a novice in the field of public health, is too basic for those who have prior experience. To remedy this (keeping in mind the entry level public health professionals) we have redesigned the ePHM course with retention of the basic components along with addition of advanced topics such as health systems, health management concepts etc for those who want to do understand public health care more in depth. This document presents a detailed description of the structure of the course with brief description of the topics that will be covered.

Structure of the Course: The new version of ePHM course has been designed to cater to the needs of both the entry level as well as mid-career public health professionals. The design of the course is such that it gives the option of incremental learning to the student so that he/she can choose till what level he would like to learn and will be awarded a certificate accordingly.

The course consists of two levels –
Level 1: Introductory concepts of Indian Public Health System and
Level 2: Advanced concepts of Public Health Systems including public health management.

The entire course is divided into 8 modules. Each module consists of four units. Each student has the option of attending a small test before starting each module. This is a test of diagnostic nature consists of questions covering the important topics to be taught in Unit 1 and 2.

If the student is able to answer more than 80% of the questions correctly then he can directly proceed to the advance units of 3 & 4 and can skip the first two units.

This process is aimed at helping students identify the topics that they already are familiar with and giving them an opportunity to directly learn the advanced topics without redoing the basics.

Call for the IPSF Internship at WHO – Famous Pharmacist Study

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IPSF is delighted to introduce you to an internship opportunity at the World Health Organization. Through IPSF, the WHO Unit for Health Promotion will recruit one pharmacy student or recent graduate to work at their main headquarters in Geneva. 

Scope: The internship offered is for a position assisting with the Famous Pharmacist Study, which focuses on the role of the pharmacist, based on review of the work of prominent pharmacists. 

Duration: The length of the internships will be from two to three months. Regarding the terms of internship, flexibility is possible, however the earliest start date is preferred.

Program & Candidate Qualifications : Under the supervision of Dr Kwok-Cho Tang, Coordinator of the Health Promotion and Noncommunicable Diseases and Mental Health department, the intern will execute various tasks in the context of the research project. Based on the nature of the project, the ideal candidate should:

• Possess excellent writing skills

• Have experience in qualitative research methods

• Have completed his or her undergraduate pharmacy study

Depending on the intern’s area of interests and skills, alongside with the approval from the WHO supervisor, IPSF additionally offers an opportunity to:

• Contribute to the IPSF Policy/Public Health Committee as a co-opted member

• Partake in the IPSF delegation to the 57th WHO World Health Assembly.

• Attend conferences and represent IPSF at United Nation meetings in Geneva with either permanent or special ground passes to UN buildings.

Eligibility: WHO may accept applicants who meet all of the following conditions as interns:

• Applicants who are fluent in English

• Applicants must not be related to a WHO staff member (e.g., son/daughter, brother/sister or mother/father)

• Applicants cannot have participated previously in a WHO internship program

• Applicants who are not current tobacco users.

Applications invited for SRF and RA : CSIR -2015

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The Human Resource Development (HRD) Group of Council of Scientific and Industrial Research (CSIR), New Delhi, provides opportunities to bright young men and women in the form of direct Senior Research Fellowships (SRFs) and Research Associateships (RAs) for training in methods of research under the expert guidance of faculty members/scientists working in universities, laboratories and institutes of Government Departments and recognised laboratories of industry in various fields of science and technology.

Preference will be given to the research topics relevant to R&D programmes of CSIR Laboratories, in the new and emerging fields of science and in the areas of importance for development of scientific and technological capability of the country. The Fellowships/ Associateships are tenable in all the universities and deemed universities/IITs/postgraduate colleges/government research establishments including those of CSIR, R&D establishments of recognised public sector, industrial firms and other recognised institutions. Only bonafide Indian citizens are eligible for the award. The award is for fixed tenure and does not imply any assurance or guarantee for subsequent employment by CSIR to the beneficiary. CSIR reserves the right to determine the place in India best suited to provide necessary facilities in the areas of science in which the awardee is to specialize. Selected Fellows and Associates will have to devote their full time to the approved research programmes. Fellows and Associates are not permitted to take up any other remunerative jobs/assignments during their tenure.

A. SENIOR RESEARCH FELLOWSHIPS

ESSENTIAL QUALIFICATIONS:

MSc/BE/B. Tech or equivalent degree with at least 55% marks and one publication in Science Citation Indexed (SCI) Journal and should have completed at least two years of post MSc/BE/B. Tech research experience as on the last date of application, as evidenced from fellowship/ associateship or from date of registration for Ph.D.

OR

MTech/ME or equivalent degree in engineering/technology with at least 60% marks.

OR

BE/B. Tech or equivalent degree with at least 60% marks and two years research experience as on the last date of application.

OR

MBBS/BDS or equivalent with at least 60% marks and one year internship.

OR

BPharm/BVSc/BSc(Ag) or equivalent degree with at least 55% marks and one publication in SCI Journal and should have completed at least three years research experience as on the last date of application, evidenced from fellowship/associateship or from date of registration for Ph.D.

OR

Apply Online on or before 14th December 2015 at http://www.csirhrdg.res.in

Novel software for Pharmacovigilance : A Pharm.D Innovation

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On the lines of the Vigiflow software technology introduced by the Indian Pharmacopoeia Commission for reporting adverse drug reactions (ADR), the Pharm D interns and faculties at the Al Shifa College of Pharmacy in Malappuram district in Kerala, with the help of software engineers, have designed and developed a new software for monitoring and reporting adverse events from patients.

The software, which is already in application at the hospital attached to the college, is known as Futura AERS (Adverse Event Reporting System), created to support the efforts of the Pharmacovigilance Programme of India (PvPI) which may find a solution to the present challenges and difficulties in detecting and reporting adverse reactions of drugs in humans. The cost-effective and minimal infrastructure requiring product can be made useful by all healthcare professionals even in rural villages.

This software can be used by healthcare professionals for reporting and retrieving an adverse drug reaction using their unique username and password. The difficulties of paper based systems and manual documentations in hospitals are avoided through this software. The software helps for storing proper database of all adverse events and they can be maintained, retrieved and communicated among healthcare professionals as and when needed.Better coordination among healthcare professionals in ADR reporting and its management is another benefit of this product. Once an ADR is reported on a drug in a particular patient, it remains in the database and can be reviewed upon the next admission of the patient.

India can become a role model to other developing countries with the introduction of this innovative software for inclusion into the pharmacovigilance programme of the country. This can help advance pharmacovigilance practices and thereby to promote patient safety and better therapeutic outcome.

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Happy Blogging...!!!

Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia