Clinical Research Project Management

CURRICUMLUM VITAE

BIBHUDATTA MOHANTY

Mob: +91-993*******

E-mail: **************@*****.***

OBJECTIVE

To associate myself with a professionally driven esteemed organization by pursuing a challenging, dynamic, responsible and rewarding carrier in clinical research field. And I hope to make significant contributions to the Nobel profession through dedication and commitment to healing the sick.

EXPERIENCES

(4.5 years)

I am working as a Sr. Clinical Research Coordinator in a Clinical Research Organization-Excel Life Sciences Pvt.Ltd (MNC) ,since 2007,Noida,India

I had worked as Clinical Research Associate (Trainee) @ IFCR clinical research institute. India.

Member of Indian Society for Clinical Research.

Therapeutic Area (Clinical Trial Done)

1. Opthalmology : A phase-III, randomized, Double blind, Multinational, placebo controlled study to evaluate Efficacy and safety of Study drug Uveitis.

2. A phase-II, randomized, Double blind, Multinational, study to evaluate Efficacy and safety of Study drug with DME (Diabetic Macular Edema).

(Comparative study)

3. A phase-III, randomized, Double blind, Multinational, study to evaluate Efficacy and safety of Study drug posterior Uveitis.

4. Diabetes: A phase-III, randomized, Double blind, Multinational, placebo controlled study to evaluate Efficacy and safety of Study drug with Type-1 DM

5. Oncology: A Randomized, Controlled Phase III Trial of Picoplatin and Best Supportive Care (BSC) versus BSC Alone in Patients with Small Cell Lung Cancer (SCLC), Refractory or Progressive within Six Months of Completing First-Line, Platinum-Containing Chemotherapy

ACADEMIC QUALIFICATION

Post graduate diploma in clinical research (PGDCR) from Inter-ed faculty of clinical research (IFCR), Kochi, Kerala. India

M.Phil-Biotech from EIILM University.

Master in Science (Biotechnology) from Berhampur University (BU).,Orissa, India

SAS(Base SAS certified)

Certificate in Computing (CIC) from IGNOU. .India

JOB PROFILE:

• Identification of potential investigators/Sites and ongoing review/ development

• Identification of potential independent review board and ongoing review/development

• Conduct of ICH GCP,ICMR/DCGI guidelines, study specific training on regular basis at the sites

• Scan patients data and short listing of patients

• Help the investigator in screening patients

• Assisting investigators in Informed Consent process, coordination and management of laboratory samples, courier and follow-ups of lab reports

• Drug accountability and dispensing at the site

• IVRS for patient randomization in randomized studies

• Investigational project management, dispensing, temperature monitoring and accountability

• Ensure compliance of project specific schedule activities

• Ensure compliance of SOPs (both internal & external as applicable)

• Preparation, attendance & follow up of Audit

• Trial close out: Preparation attendance and follow up; forwarding the necessary information of site closeout to all concerns

• Manage & develop investigators in respective region

• Verify the accuracy and validity of data entered in database; correct any errors

• Prepare tables, graphs, fact sheets, and written reports summarizing research results

• Submit reports & research findings to internal & external costumers

• Compiling verifying information or data

• Manage site CTAs and their payment milestones

• Manage patient travel reimbursement

Professional Skills:

• Excellent time management and project management skills.

• Excellent Communication skill

• Knowledge about ICH-GCP and local regulatory laws and guidelines.

• Knowledge about EDC (e-CRF), CRF, IVRS.

• MS-Office (Word, Excel, Power point)

PERSONAL DETAILS

Date/ Place of Birth : 13th July 1984 (INDIA)

Sex : Male

Nationality : Indian

Marital status : Unmarried

Languages known (vocal/scripts) : English, Hindi, Oriya

Permanent address : Niladrinagar, Balimela, Malkangiri

Orissa, India-764051

DECLARATION

The above-furnished data are true to the best of my knowledge & belief.

Date-15-Apr-2012 Bibhudatta Mohanty

**************@*****.***

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