Clinical Trial Associate required at Sun Pharma "A"

Job Description

• Prepare and procure documents for clinical dossiers for DCGI and/or USFDA submission; as applicable
• Prepare dossiers for EC submission
• Assist PM in site selection process and document collection
• Facilitate and coordinate with investigator and site for EC submission and approval
• Prepare Confidentiality Disclosure Agreement (CDA), Feasibility Questionnaires and Clinical Study Agreement (CSA) with investigators in collaboration with the project manager
• Get trained on the study and documentation requirements
• Prepare for kick-off meetings to train vendor representatives involved if out-sourced activity for monitoring.
• Prepare presentation and documents and Start up kits for site initiation
• Coordinate with translating and back translating agencies for PIS ICF and other associated documents

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Urgent Opening at Quintiles "A"

Job Description

Multiple Job Opportunities for candidate looking for Sr.CRA/ In House CRA/ Remote Site Monitor roles.


Work Experience: 2 to 4 years.


Skills: Clinical Research, ICH - GCP, Remote Site Monitoring, In House CRA, Risk Based Monitoring, On Site Monitoring.

Clinical Role: Sr Clinical Research Associate/ Sr. Clinical Process Associate

PURPOSE
Provide project related assistance for assigned complex project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

RESPONSIBILITIES
Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
Establish and maintain effective project/ site communications
Create and maintain relevant project documents
Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
Participate in document management (creation, review, maintenance, storage, as applicable)  


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Sun Pharma hiring Clinical Research Associate "A"

Job Description

1. Facilitate and coordinate with investigator and site for EC submission and approval.
2. Conduct site feasibility and qualification visits.
3. Get trained on trial and documents.
4. Prepare for kickoff
5. meetings to train vendor representatives involved if outsourced
6. activity for monitoring.
7. Coordinate with investigator and sites for IM and assist PM in planning for IM
8. Conduct SIVs, write SIV reports, and dispatch to sites
9. Resolve queries and problems at sites and with vendors.
10. Monitor sites, write monitoring visit reports and send timely monitoring followup
11. letters to sites.
12. Obtain updated weekly trackers from sites
13. Report SUSARs to regulatory authorities and all SAEs to sites, ECs, and investigators.
14. Coordinate with data management team and investigator/site team for timely DCF resolution.

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Biocon hiring Biostatistician "A"

Job Description

-Performs biostatistical and programming activities for given clinical trials involving drugs, biologics and medical devices.
-Responsible for all statistical tasks with a high level of independence e.g. clinical trial design/planning, sample size estimations, analysis plan, defining safety, efficacy and exploratory endpoints, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase .
-Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Within the context of biological product development, defines, recommends, analyses and interprets the statistical part of projects in order to guarantee the statistical reliability of the conducted studies and dossiers and to allow the world-wide registration in compliance with the clinical development plan, good practices.
-Ensure timeliness and adequate quality of all deliverables for the assigned trials and project tasks. Able to manage CRO deliverables.
- Follow processes and adhere to Health Authority requirements (SOP's, GCP and regulatory guidelines).Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/Global Clinical Trial Teams

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Sun Pharma hiring for Sr. Manager Clinical Research "A"

Job Description

• Act as a medical resource to the company as a whole and particularly to the clinical research department (protocol, CSR writing/ review, adverse events, discussions with investigators, internal meetings). 
• To have responsibility for nominated therapeutic areas and assume overall management of the clinical trials within these areas 
• To be recognized as a company expert in the nominated therapeutic areas and provide input into in product development teams. 
• Represent the company via presentations to groups of experts, societies, regulatory bodies and at international meetings. 
• Write clinical development plans, develop budgets, & provide drug development inputs 
• Establish ongoing liaison with key opinion leaders and to ensure that significant developments in the field are identified and monitored. 
• Provide medical expertise in the review of adverse experiences and discuss patient management issues with investigators. 
• Attend and contribute to interdisciplinary team meetings relating to clinical investigational drug trials 
• Effectively collaborate with colleagues in related project team departments such as Regulatory, Quality Assurance, anufacturing, Bioanalytical , PK/PD, Discovery, and Marketing 

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Inventiv Health hiring Drug Safety Physician "A"

Sr. Drug Safety Physicians

Job Description

Responsibilities
Medical review of adverse events reported to investigational and marketed products including identification of event/s, confirmation of seriousness, ensure that events are coded and mapped to the appropriate terms in MedDRA, provide assessment of expectedness per reference safety information, assessment of causality, review of narrative for chronology and medical content and provide medical evaluation comment.
Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment.
Ensure regulatory compliance with respect to the evaluation, reporting and surveillance of safety information.
Identify, communicate, and effectively manage potential safety issues.
Provide medical safety analysis and interpretation for periodic safety aggregate reports (e.g. DSUR, PSUR/PBRER, PADER, bridging reports, and other relevant aggregate report/analyses).
Interact with clients safety/medical personnel as appropriate to ensure above.
Maintain a working knowledge of projects in the functional area for which inVentiv Health Clinical safety is responsible for safety reporting.
Stay abreast of clinical and drug development information relevant to contracted programs by review of literature and by maintaining training.
Serve as a mentor for other internal safety staff including case processing staff.

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Biocon hiring Medical Advisor "A"

Medical Advisor - Oncology

2 - 5 Years

Bengaluru/Bangalore 

Job Description

• To provide medical support to marketing team in strategizing brand plans and sales team.
• Providing scientific and medical input to  Product Management Team for development of visual aid, LBLs, Recent guidelines, Treatment algorithms, Reference folders and patient education literature.
• Conduct medical and orientation programme on Anatomy, Physiology , various related Clinical conditions and Product based knowledge to newly inducted sales employees.
• To develop Protocol, CRF's and other trial related documents, coordinating with Investigators ethical committee submission for all the Phase IV, PMS and Investigators initiated studies. 
• To meet KOL's and Investigators to develop a mindspace for Biocon and provide scientific support.

 Company Profile

Biocon is an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing, manufacturing and global marketing, Biocon delivers products and solutions to partners and customers in over 75 countries. Biocon has the defining science, world class capabilities and a focused vision to deliver the promise of innovative and affordable medicine to a waiting world. Today, Biocon together with group companies employs more than 5000 employees with approxmimately Rs 2500 crore turnover and is expected to grow further during the current financial year .

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Explore the world of Opportunities in Pharma Industry.

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Quintiles hiring for CRA "A"

 JOB! Openings at Quintiles - In House CRA Role

Quintiles

2 - 4 yrs

Thane

Job Description

Dear  All,


We are pleased to let you know that we have multiple openings for experienced Clinical Research Professionals for In House CRA (Remote/Risk Based Monitoring) role.


Skill Sets/Knowledge Required - Clinical Research, CRA, CRC, Risk Based Monitoring, Remote Monitoring, ICH - GCP, Clinical Trials


Overall and Relevant Experience - 2 to 3.5 years 


Job Location - Thane (Mumbai)


Interested Candidates kindly send your CVs on Goldy.Sachdev@quintiles.com


Job Description


PURPOSE
Provide project related assistance for assigned complex project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.

RESPONSIBILITIES
Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
Establish and maintain effective project/ site communications
Create and maintain relevant project documents
Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
Participate in document management (creation, review, maintenance, storage, as applicable)

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Good knowledge of applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws,
regulations and guidelines
Strong written and verbal communication skills including good command of English language
Results and detail-oriented approach to work delivery and output
Good problem solving skills
Good planning, time management and prioritization skills
Attention to detail and accuracy in work
Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel
and PowerPoint
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Proven ability to work on multiple projects balancing competing priorities
Ability to coach/ mentor junior colleagues

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in life sciences/pharma or related field and min 2 years relevant experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
May require working in shifts.

Company Profile:

Quintiles

Quintiles is the world's largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions - from pipeline through portfolio to population health â„¢. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.  

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Clinical Research Associate required for Sitec Labs "A"

Clinical Research Associate.

Sitec Labs Private Limited

0 - 1 yrs

Navi Mumbai

Job Description

Medical writing, Preparation of protocol, case record forms, informed consent forms etc. Preparation of study summary, submission of proposal to IEC / IRB, preparation of clinical study reports. AE documentation,summation of reports and review.

Company Profile:

Sitec Labs Private Limited

Sitec Labs Pvt. Ltd., an ISO 9001:2008 Contract Research Organization (CRO).  

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Hiring for B.pharm Research Analyst "A"

WNS Hiring for B.pharm Research Analyst - Meet HR Pooja 02240112935

0 - 5 Years

Mumbai

Job Description

Greeting from WNS!!

WNS Hiring for Pharma Research Analyst

Walkin from 31st Aug - 2nd Sep 
Contact HR Pooja 02240112935.

Job description and key accountabilities:

Research and analyze business impacting and time sensitive business information in the Biopharmaceutical Industry.
BioPharmaceutical Databases Development through Business Research, Information analysis and profiling in given format for:
1. Drug database:
Researching through various company websites and collecting the details (such as molecule, chemical structure & properties, mechanism of action, therapeutic area, clinical phases etc) of marketed drugs and drugs under developmental pipelines

2. Life science conference Database:
Searching and capturing details on upcoming biopharmaceutical/ Life science conferences. Details about the location, conference title, speakers, sponsors, exhibitors or media involved are captured

3. Active Intel:
Researching & tagging the Biopharmaceutical Industry news/articles to the database

4. Clinical Trials:
Understanding & tagging the Conditions, Interventions & Sponsors to the Clinical Trial Database
.
5. Pharmaceutical Licensing agreements:
Capturing the details of pharmaceutical licensing transactions from company websites or Securities and Exchange Commission (SEC) files, annual reports etc

6. Ad Hoc Tasks:
Working on any Ad Hoc, short duration assignments/projects assigned by clients related to Biopharmaceutical Industry.


B.Pharma Grad
Minimum work experience: 0

Candidate Boundary Limits: Churchgate / CST till Mira Road, Kharghar and Kalyan
Drop / Pick Up Points: Dadar / Borivli / Vashi / Thane.

Special skills:
Excellent Communication Skills
Keen Interest in Secondary Research
Ability to interpret data and aid in arriving at the key findings
Decision making and judgment
Proficient in MS Office

Shift Timings: Rotations Shifts (7am 2.30pm, 2.30pm 10pm )

Interview Venue:
WNS Global Services,Plant 5, Gate NO 2, Godrej Compound,LBS Marg, Vikhroli West. Near Caf Coffee Day. Landmark: Caf Coffee Day.

Contact Person: Miss Pooja.P

Synopsis about WNS:
WNS is a leading global KPO and BPO company. WNS has a strong horizontal focus with its Finance & Accounting, Contact Center and Research & Analytics solutions. WNS 'extends the enterprise' of some of the world's best brands by providing vertical-led solutions for Travel & Leisure, Banking & Financial services, Insurance, Shipping & Logistics, Utilities, Healthcare, Manufacturing, Telecommunications, and Retail & Consumer Packaged Goods industries.
 Company Profile

WNS is a leading global KPO and BPO company. WNS has a strong horizontal focus with its Finance & Accounting, Contact Center and Research & Analytics solutions. WNS 'extends the enterprise' of some of the world's best brands by providing vertical-led solutions for Travel & Leisure, Banking & Financial services, Insurance, Shipping & Logistics, Utilities, Healthcare, Manufacturing, Telecommunications, and Retail & Consumer Packaged Goods industries

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