Clinical Trial Monitor - Phase Studies : Manipal Acunova Ltd

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Clinical Trial Monitor - Phase Studies : Manipal Acunova Ltd

Role : Clinical Research Associate / Scientist

Number of Openings : 03

Experience required : 1-4 years 

Location : Bangalore

Ecron Acunova provides end-to-end services for Phase I-IV clinical research, including Clinical Trial Management, Clinical Data Management, PK/PD services and Central Lab. Ecron Acunova has research facilities in Asia as well as an established presence in various parts of Europe and the United States. We offer clinical development services to the pharmaceutical, biotechnology, nutritional, device and medical diagnostics industries. Our service quality, therapeutic expertise and global reach have allowed us to grow rapidly, building a list of demanding clients. We provide an attractive package of services coupled with the ability to rapidly conduct clinical trials utilizing a world class delivery platform.

Job profile: 

The responsibility is to perform all clinical monitoring aspects of designated projects in accordance with applicable SOP and regulations. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH-GCP guidelines.

1. Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM.
2. Preparation, conduct and reporting of site selection visits.
3. Negotiation & obtaining Investigator agreement on site budget, payment to the sites.
4. Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents.
5. Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner.
6. Maintenance of TMF and Site specific file.
7. Scanning & uploading documents into shared drive.
8. Transmission of documentation into project files.
9. Preparation of regulatory dossier, regulatory submission and follow-up.
10. Preparation of EC dossier, EC submissions and follow-up.
11. Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting.
12. Development of meeting materials along with required presentations for investigators meeting.
13. Site initiation visit planning, preparation, conduct, report and follow-up of pending issues.
14. Co-ordinating the IP request between sites and pharmacist/ vendor/ sponsor. 

Desired Candidate Profile :

UG : B.Pharma - Pharmacy, PG : M.Pharma - Pharmacy, Doctorate : Any Doctorate - Any Specialization, Doctorate Not Required

Worked in Ophthalmology or Oncology studies Clinical Studies I-IV

1. Ability to interact professionally with clients/vendors.
2. Excellent interpersonal, verbal and written communication skills and ability to work in a team.
3. Effective time management skills and prioritize tasks to manage study timelines.
4. Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word etc, sound presentation skills.
5. A minimum of 65% on average.

Recruiter Name : M. Chaarumathi

Email Address : careers-asia@ecronacunova.com 

Website : http://ecronacunova.com/

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Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia