NeuroMolecular Bangalore : Clinical research Manager

[mskavi]

NeuroMolecular Bengaluru/Bangalore : Clinical Program Manager

Website: http://www.adamaspharma.com

Keywords: Clinical research, Clinical Program Manager, Pharma, Bangalore

Designation: Clinical Program Manager
Experience: 6 - 11 Years
Location: Bengaluru/Bangalore
Compensation:
Commensurate with experience and competitive with market
Education:
UG - B.Sc - Any Specialization
PG - M.Sc - Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 22 Jan

Job Description:
Develop study timelines, milestones and budget in collaboration with project subteam members
Develop study protocols with guidance from Clinical Research Physician, case report forms, informed consent forms and other study-related documents
Review and qualification of investigational sites
Manage a Clinical Operations team in a matrix environment; provide program-specific leadership, guidance, clinical trial management expertise and direction to achieve results, and provide timely and direct feedback to functional managers
Represent Clinical Operations as a member of the Development subteam
Provide timely and accurate input to clinical development plans including forecasting of timelines, assessment of feasibility for protocol design, estimation of resources, and program level budget
Select, manage and oversee CROs to ensure that clinical studies are executed properly, on time and in compliance with GCPs
Collect and archive documents for inclusion in the Trial Master File

Review and finalize clinical study reports – ensuring reports QC’d, signed off and published with copies going to Regulatory Authorities and Ethics Committees (as required)
Ensure compliance by Clinical Operations staff through familiarization with and understanding of all relevant SOPs

Desired Candidate Profile:
Minimum of a Bachelor of Science degree in a relevant scientific discipline
7+ years' CRO or pharmaceutical company experience, as Clinical Research Associate with thorough knowledge of planning, implementing, and managing single and multi-center clinical trials
Strong written and verbal communication, interpersonal, and negotiation skills
Proven organizational skills; ability to present to diverse groups of clinical staff (at project or investigator meetings)
Ability to manage multiple priorities and work under pressure
Detailed knowledge of project management, ICH guidelines and corporate/ regional SOPs
Computer software: Microsoft Word, Excel, PowerPoint, Project, Visio
Knowledge of 21 Code of Federal Regulations Title 21 Parts 11, 50, 54, 56, 312, 314; International Conference on Harmonization Guidelines E6 (Good Clinical Practice: Consolidated Guidance), E2A, E8 and Guidelines from other Regulatory Authorities pertinent to planned studies
Ability to travel

Company Profile:
NeuroMolecular Pharmaceuticals India Pvt. Ltd Founded in 2002, NeuroMolecular Pharmaceuticals India Pvt. Ltd. / Adamas Pharmaceuticals, Inc.
is a global specialty pharmaceutical company focused on the development and commercialization of improved combination therapeutics to treat important healthcare problems. Our initial focus is on novel therapeutics for neurological disorders and viral infections. Headquartered in Emeryville, California, Adamas has operations in the US, India, and Singapore.


We have established infrastructure in Bangalore, India (NeuroMolecular Pharmaceuticals India Pvt. Ltd.) to facilitate development, manufacturing and clinical evaluation capabilities available in India, Singapore, China and Australia.

Please submit your inquiries to hr@adamaspharma.com. For further information, please visit www.adamaspharma.com

Executive Name: Bindu John

Address:
Not Mentioned

Email Address: hr@adamaspharma.com

Telephone: 91-080-42456900

Keywords: Clinical research, Clinical Program Manager, Pharma, Bangalore

[Guest-IJT]

CURRICULUM VITAE
Navakanth. B Mail: bnavakanth AT gmail.com
Mobile: 09490213573

Objective:
Focus on a challenging career in an industry seeking a quality environment where my knowledge can be shared and enriched looking for the opportunity where I can improve my skills.

Personal Skills: Comprehensive problem solving abilities, Ability to deal with people diplomatically, willingness to learn, Team facilitator.

Area of interest:
Bioavailability & Bioequivalence
Pharmacovigilence
Clinical Research (Associate/Auditor/Coordinator)


Education Summary:

S.No COURSE
INSTITUTION YEAR %OF MARKS

1.
M. PHARMACY (Pharmacology) Annamalai university,

Chidambaram.
2007-2009
7.8 CREDIT POINTS

2.
B.PHARMACY R.I.P.E.R.
ANANTHPUR,
J.N.T.U., HYDERABAD.
2003-2007
70 %

3.
INTERMEDIATE
Goutham jr. college,
vijayawada
2001-2003
81 %
4. S.S.C Bhashyam public school,
Guntur. 2000-2001 87.5 %


Present status:
Working as a Assistant Professor in MITS college of pharmacy, kodada from July 2009 to till date
Academic project:
Project: Assessment of safety and efficacy of fixed dose combination of Glimeperide and Metformin in patients with type 2 diabetes mellitus.
Duration: 8 months.
Role: Trainee Clinical Research Coordinator
Organization: Mediciti Hospital, Hyderabad.

Responsibilities:

- Perform enrollment, screening, randomization and close-out activities.

- Telephonic visit and record of the same.

- Communicate with the sites on administrative matters.

- Report patient status at site to principal investigator / Project Manager.

- Review patient related logs, forms and report in-house.

- Track protocol deviations, adverse events and study material at sites.

- Serious adverse event reporting & record of the same.

- Maintain documents related to the sites in-house.

- Perform administrative duties including attendance at clinical monitoring staff meetings, project team meetings and clinical training sessions.

Software Skills:
Operating Systems : MS-DOS, Windows 95/98.
Office Tools : MS-Office 2007, MS-Excel 2007.


Conferences attended:
- Attended Indian pharmaceutical Congress (IPC) Programme held in Hyderabad
- Attended a National conference on ANIMALS WELFARE & ETHICS held in ANNAMALAI UNIVERSITY, CHIDAMBARAM.
References:
Dr. Naveen Chander Reddy M.D Dr. V. Parthasarathy M.Pharm. PhD,
Cardiologist & Clinical research Co-ordinator, Professor,
5-9-22, Mediciti Hospitals, Department of pharmacy,
Secretariat Road, Annamalai University,
Hyderabad-500063. Tamilnadu.

Personal Profile:
Name : B.NAVAKANTH
Father’s Name : B.SAMBASIVA RAO
Date of Birth : 05-05-1986
Sex : Male
Marital Status : Single
Nationality : Indian
Address : S/o sambasiva Rao
Attaluru (v)
Amaravathi (m)
Guntur (D)
Andhra pradesh-522436
Languages Known : English, Hindi and Telugu

Declaration:

I here by declare that the information furnished above is true to the best of my knowledge

Yours Sincerely,
B.NAVAKANTH

[Guest]

hai iam mohd muddaseer,recently completed my Bpharma course and looking for a clinicaltrails job in bangalore,here iam attaching my resumeRESUME
MOHD MUDDASEER
E-mail ID : . skmdser AT yahoo.com

To work in a dynamic, challenging environment that allows me to fully utilize my education and skills and also seeking a challenging job in an organization, where I can explore myself, contribute my overall inputs and aiming for the growth of the organization.
Clinical trials, As a clinical research associate, coordinator
Course : B-pharma
Institute : MILIND INSTITUTE OF PHARMACY, Bangalore
University : RGUHS University, Bangalore.
Year of completion 2011

Course : D-pharma
Institute : GOVT COLLEGE OF PHARMACY, Bangalore
Board : Drug control board of karnataka
Year of Passing : 2002
Percentage of marks : 66.42%
Course : INTERMEDIATE
Institute : Madhuvidyanikethan junior college,palamaner
Board : Board of Intermediate Education, AP.
Year of Passing : 2000
Percentage of marks : 64
Course : SSC
Institute : Bramharshi residential school
Board : Board of Secondary Education, AP
Year of Passing : 1998
Percentage of marks : 69
- Easy to adjust with new environment and achieve the goals.
- Ready to face challenges which are useful to my career for my bright future.
Organization : Juggat pharma., Mysore road, Bangalore.
Period : From Feb 2004 to Feb 2006
Designation : production officer
Organization : Cipla Ltd., Virgo Nagar, Old Madras road, Bangalore.
Period : Feb 2006 to March 2007
Designation : Management staff member-production officer
B.PHARMACY :2007 – 2010
Now after completion of my B pharma course I want to start my career in cro industry,please give me opportunity.
- Employees to implement CGMP requirements.
- Experienced in QA-IPQA
- Document Review, Investigation, Dispensing activities.
- Experienced in manufacturing of Tablets, capsules to regulated market.
- Well Experienced in record entries & Maintenance of documents as per the CGMP requirements

[Guest]

RESUME
Mrs. Smita S. Bhakare
S_bajad AT rediffmail.com

To work in a creative, exciting research-oriented setting that would expand my knowledge and provide focus on success of the reputed pharmaceutical organization.
Examination Year University/Institute Marks%
M. Pharm IInd
(Pharmaceuticalchemistry) July 2010 Amravati University 69%
M. Pharm Ist
(Pharmaceuticalchemistry) June2009 Amravati University 62 %
B.Pharm June 2008 Amravati University 60%
D.Pharm June 2005 Amravati University 76%


Project Title “SYNTHESIS OF NITROGEN CONTAINING HETROCYCLIC COMPOUNDS AND CO-ORDINATION MODE OF NOVEL SCHIFF BASES : QSAR, SPECTROSCOPY AND ANTIMICROBIAL STUDY”

Research Guide : R.A. Hajare ,
Scope of Project :
- QSAR is new trend and effective technique Use to generate a QSAR model from all structures that have already been synthesized and tested, and then use the model to synthesize more potent compound.
Research Interests Regulartory Affairs, Synthetic Chemistry, HPLC Analysis .

R.A.Hajare, K.S. Parwani, S.A. Bajad, N.A.Chandekar, A.V.Chandewar.
“Breast cancer and Indole -3-carbinol : Controversy of estrogen level and enzyme
Elastase’’ Paper No. I- 281/13-02-2009, pp 439-440, Research Journal of Pharmacy and
Technology.

R.A.Hajare, S. A. Bajad, K .S.Parwani, N.A.Chandekar, A.V.Chandewar
“Therapeutic Potential of Curcumin in Prostate Cancer” Nov. (2009), pp 123-124,
THE PHARMAREVIEW.
R.A.Hajare, A.Meshram, P.A.Raut, A.D.Chavan, S.A.Bajad, N.A.Chandekar, A.V.Chandewar “Insulin Chewing Gum can Help Tackle Diabetes Epidemic : Track to Develop” Vol.04/ Issue I/February 2010 pp 42-43, (2010), JOURANAL OF GMP AND INDUSTRIAL PHARMACY.
Professional Training Successfully performed 1 Month Industrial training in
“LEBEN LABORATORIES PVT.LTD. “ M.I.D.C, AKOLA 444104.
Computer Proficiency Windows operating systems and Internet and Data base searching

I hereby declare that all the above details furnished are true to the best of my knowledge and belief.
Place :


Mrs. Smita S. Bhakare