Clinical Project manager

Rohan Mammen

***** ******* ***, **********, ** **874 240-***-**** ***********@*****.***

Regulatory Affairs & Clinical Project Manager

Objective

Seeking a position in the field of Clinical Research with an emerging globally focused organization that would purposefully utilize my skills while offering several opportunities to integrate personal enrichment with my professional and personal goals.

Education

University of Maryland Baltimore County-Bachelor of Science in Biological Sciences

University of Maryland UC Masters in Information Technology-Project Management Technology (2010 – 2012(Expected))

Skill Summary

Systems: LINUX, Windows 9X/NT/2000/XP/2K3/Vista/7, Mac OS

Databases: Oracle, MySQL, Relational Databases

Languages: SQL, HTML, C/C++, Java

Software:

MS Office Suite (Excel, Visio, Word, PowerPoint, Project, Access). Knowledgeable in the use of Bio-Informatics tools and databases for the analysis and research of nucleic and protein sequences

- PubMed, EBI, Ensembl, BLAST, FASTA, HMM, ClustalW - Good knowledge of the tools’ algorithms

Clinical Research Skills • Progressive three years of professional experience in clinical trial

• Comprehensive knowledge of clinical practices, clinical trial monitoring and design controls

• Familiar with the practices and methods of clinical trial methodology and research

• Extensive knowledge of clinical trial management systems as well as the design and implementation of clinical trials

• Proficient in FDA regulatory compliance matters and well versed in ICH, cGMP, cGLP, and cGCP

Experience

Medispec Ltd(December 2010- now)

Regulatory Affairs & Clinical Project Manager

Department Manager for Regulatory Affairs and is currently responsible for the overview and management of clinical trials of Medical Devices, compliance monitoring, and all other FDA related scientific and regulatory issues. Responsibilities include:-

•Manage and review all FDA related regulatory affairs and processes and assist with the review of technical/device description issues.

•Liaison between manufacturing, service, R&D, QA and the regulatory affairs department with regards to operation and service updates, product changes, new product development and regulatory compliance.

•Assist with clinical protocol development including statistical review.

•Assist with clinical trial management to include, compilation and review of site study materials, clinical monitoring and data collection, IRB correspondence, submissions, and renewals, investigator's brochure, and Pre-market materials.

Cardiocore (July 2007-November 2010)

Clinical Data Technician (Consultant)

Assisted in the verification of protocol-specific subject information for ECG and Holter studies, and was involved in management of the data query and resolution process which led to the resolution of possible anomalies, and thereby performed quality control for data which needed to be processed. Also participated in supervised Client site support and applied the skills necessary when assistance was required in the clinical data collection process.

CVT (Consultant/Intern)

Performed analysis and quality control of Holter monitor scans, Electrocardiograms and Echocardiograms acquired digitally from clinical trial sites.

American Society for Engineering Education, Washington DC (July 2003 – August 2005)

Intern

Was involved in various survey-based data collection, with extensive use of Microsoft based applications such as Word, Excel, and Access.

Certification/Training

NCBI Bioinformatics Workshop (Spring 2008)

NIH organized training workshop on NCBI based databases covering effective use of the PubMed, Entrez databases, and the BLAST similarity search engine.

Contact this candidate