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Career as Feasibility Specialist in Quintiles

 

Clinical courses

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level o f healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.

Post: Feasibility Specialist 1-1420767

Job Description
Under the supervision of the Project Manager - Site Management Services, performs the following activities within pre determined timelines

1. Conduct of the Feasibility:
a) To understand and analyze the need and the timelines for the conduct of the feasibility as requested by Business Development (BD)/Internal Departments of Quintiles.
b) Reviews and understands the available study details like protocol, protocol synopsis for the conduct of the feasibility.
c) Identifies the potential investigators to be contacted for the conduct of the feasibility.
d) Attend the teleconferences with the Client/Global team as required
e) Prepares and obtains the signed Confidentiality Agreements as required.
f) Contacts potential investigators to discusses the study details with Investigators in brief providing critical information needed to obtain the feedback desired, to the assess the feasibility of the proposed study.
g) Prepares and reviews the feasibility questionnaire.
h) Prepares the correspondence to the site to send the study details, questionnaire and related matter to obtain the feedback as required.
i) Reviews, collates and analyses the feedback received from the Investigators and prepares the reports.
j) Forwards the report in detail to the feasibility requestor as desired.
k) Prepares the telephonic contact reports as desired.
l) Files the filled in questionnaire, relevant correspondence and related documents and updates the contact list.
m) Updates the Investigator's database on the regular basis.
n) Updates and maintains the soft copy of the feasibility folder on a ongoing basis as required.
o) Reports regularly to the relevant parties involved, informed about the status of the feasibility at all the stages.
p) Identifies issues and arranges for resolutions by relevant personnel.


2. Identification of New sites:
a)   To proactively identify the new sites keeping in mind the business trend and the need for the new sites across therapeutic areas.
b)  Performs the site visits for site evaluation as needed. Prepares internal site trip reports, recommending actions where appropriate and documents the decision of the site visit.

3. Investigator's Database:
a) To help creating the database of the existing as well as new & potential investigators
b) To update and upgrade the Investigator's database.


4. Site Relationship:
a) To help maintaining the site relationship by contacting the Investigator's at regular intervals to help  marketing Quintiles.
Performs administrative duties including attendance at SMS staff meetings, committees, clinical training sessions, etc.
Identifies and records quality problems primarily pertaining to the conduct of the feasibility and site identification as well as site relationship. Suggests, initiates, recommends and/or provides solutions as appropriate.
Attends refresher-training sessions, organized by L & D Department as directed. Participates in specific training programmers, and serves as a mentor for new staff of SMS
Maintains awareness of overall developments in the field of clinical research, as well as assigned areas, by reading related literature, attending professional meetings, etc.
Performs other study related tasks as assigned by supervisor.
Performs administrative duties as directed.

Candidate Profile
Degree (Bachelor's or Master's) in a scientific discipline.
1- 2 years of exp as CRC/CRA.
Training as Site Startup Specialist/CRA in Quintiles as per Quintiles India Clinical Operations/SMS Training policy or equivalent work experience in the CRO/pharmaceutical industry

Additional Information:
Qualification: Any
Location: India
Last Date: 14th December, 2014
Job Id: 1420767

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