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Project Manager Clinical Research

Location:
New Delhi, DL, 110065, India
Salary:
Negotiable
Posted:
August 11, 2012

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Resume:

VIJAY KUMAR

Mobile No: +91-999******* Email Id : vzdv0o@r.postjobfree.com

OBJECTIVE: To work with growth oriented organization where my skills could be effectively utilized

and enhanced to contribute to the success of the organization.

PROFESSIONAL EXPERIENCE:

• Working for Max Neeman International since 15thFeb 2010 till date on following studies:

S.No Therapeutic Area Phase Role

1. Pneumonia III Unblinded Coordinator

2. Diabetes IV Project In charge

3 Diabetes IV Regional In charge

4. Diabetes IV Regional In charge

5. Cardiology IV CRC

6. Oncology III CRC

7. Oncology II CRC

8 Diabetes IV (2 studies) CRA

9 Diabetes IV (3 studies) CRC

Job Profile-

Coordinating regularly with CRC for smooth functioning of the project.

Conduct SIV, and provide training to the site staff involved in the study.

Conduct on-site clinical monitoring which includes: document review, ensuring accurate data recording, verifying patient data, adherence to the protocol of a clinical trial in accordance with GCP/ICH guidelines.

Maintaining regular contact with study sites to ensure protocol/GCP compliance.

Communicate progress of study and relevant information to Project Manager/Sr. CRA and other project team members.

Review SAE form and facilitate AE/SAE reporting.

Review and update Investigator site file regularly.

Regularly updating the study trackers.

Liaising with the site and the sponsors to meet the goals and deadlines.

Plan, organize and conduct site feasibility.

Coordinating the P.I during ICF process.

Patient screening and enrollment.

Scheduling Patient visit.

I.P dispensing and accountability.

e-CRF filling.

Assess potential study sites to insure the facility, staff and patient population are sufficient for study conduct.

Assist the Principal Investigator at the site for smooth progress of the study.

Scheduling patient visits and study procedure as per protocol and SOPs.

Patient screening and recruitment as per inclusion/ exclusion criteria.

Managing day to day activities of the study.

Arranging scheduled patient laboratory sampling (like- FPG, HbA1c, Lipid profile etc.).

Communicate progress of study and relevant information to Project Manager/Sr. CRA and other project team members.

Completing and ensuring the quality of CRFs within timelines.

Ensuring proper documentation in Source Documents.

Tracking the status of all study related activities as per protocol and other applicable regulatory requirement.

Query resolution in time.

Serving as the primary contact with Sponsor/ CRO/ Lab. / Vendor.

EDUCATIONAL QUALIFICATION:

M.Sc. in Clinical Research (2009): ICRI, New Delhi.

Post Graduate Diploma in Clinical Research Management (2008): ICRI, New Delhi.

B.Sc. Bioinformatics: Devi Ahiliya Vishwavidyalay, Indore (M.P).

CONFERENCE/TRAINING ATTENDED:

• Attended Investigator meeting for different trials.

• International Conference on “GLOBAL TREND IN CLINICAL RESEARCH”, held at Hotel Intercontinental the Grand, Mumbai on March (14th- 15th), 2008.

• Workshop on “STRUCTURAL BIOINFORMATICS”, held at Bhopal on January (18-20), 2007.

STRENGTH:

• Good analytical and learning skills.

• Taking Responsibilities.

• Can work under pressure.

• Hand on experience on Computer.

• Proactive team player.

• Ability to put in 100% effort into my work.

PERSONAL DETAIL:

• PERMANENT ADDRESS:

Sector- 6A, Quarter no-3242, Bokaro Steel City, Jharkhand, Pin -827006.

• CURRENT ADDRESS:

6/2, 3rd Floor, Room No: 03, Nehru Nagar, NEW DELHI

• DATE OF BIRTH : 28/02/1984.

• GENDER : Male.

• MARTIAL STATUS : Single.

• LANGUAGE : English, Hindi, Bengali.

I do hereby declare that all the information furnished above are true, complete and correct to best of my knowledge and belief.

Date - 09/08/2012

Place - New Delhi Vijay Kumar



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