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Clinical Research Management

Location:
Los Angeles, CA
Posted:
February 15, 2016

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Key Skills

Employment History

July **** – Present

Senior Industry & Contracts Officer

Aug 2012 – June 2013

Dec 2010 – July 2012

Negotiation of Complex Contracts, Budgeting, Contract Management, Intellectual Property Rights, Licensing, Project Management, Customer-care, Networking, Team Player, Leadership Skills, Strong Communication Skills.

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Responsible for management and administration of clinical trials for various departments sponsored by pharmaceutical industries. Responsible for review, negotiation and management of contract and budget negotiation, financial tracking, overall management of projects for all Phase trials and investigator-initiated trials. Draft, review, and negotiate broad range of contracts including master service agreements, related SOW, work orders, clinical trial agreements, research agreements, licensing Agreements, service agreements, consulting agreements, collaboration agreements, material transfer, data use agreements and non-disclosure/confidentiality agreements. Negotiate and handle issues relating to indemnification, intellectual property rights, subject-injury, publication, insurance, monitoring, reporting, AAHRPP related language among other terms. Use strong business acumen in negotiating projects that protect the Institution and Investigators. Ensure that the contracts comply with applicable laws, institutional policies and industry practices.

Coordinate contract negotiations involving multiple parties while maintaining positive sponsor relations and protecting Institution's interests. Manage clinical trial portfolios for multiple medical department and divisions, maintain daily contact with study counterparts and clients. Maintain excellent documentation, monitor financial status and oversee financial management of revenue and account payables and receivables for multiple industry sponsored clinical trials and other agreements. Work closely with principal investigators, study coordinators, department administrators, institutional review board members, accounting, external legal counsels, clinical research organizations and industry sponsors/agencies to ensure seamless execution of clinical trial studies from contract negotiation and award management to post-award maintenance and close-out.

Legal Consultant, Robert Half Legal

Doll Amir & Eley LLP, Contract Review (Nov – Dec 2012)

Responsible for extensive and detailed review of contracts for a class action law suit to check the level of adherence and violation in comparison with contract law. Reviewed, analysed and coded the contracts based on the relevancy of the documents by using Relativity software. Responsible for examining hundreds of automobile lease agreements to code the inclusion or absence of certain terms in the contracts.

Gordon & Rees, LLP, Document Review (Aug 2012 – Sept 2012)

Responsible for review, analysis and redaction of electronic discovery of various commercial documents (agreements, correspondence, and reports) by using software tool (Applied Discovery). Conduct document review during the discovery phase of litigation. Assess the relevance and responsiveness of documents, using knowledge about the facts of the case and issues of law. Redact irrelevant information based on the facts of the case and issues of law. Consider whether reviewed documents are privileged on the basis of attorney-client communication or work product. Being compliant of HIPAA regulations in protecting the patient details and information.

Independent Legal Consultant

Responsible for drafting, vetting and negotiating various agreements for start-up companies. Advising on Intellectual property rights and its effective protection. Review, draft, negotiate and advise on various contract issues, risk analysis and mitigation. Reviewing request for proposals, source code agreements, work orders, non-disclosure/confidentiality agreements. Advised major pharmaceutical industries and Clinical Research Organization on various issues and contract terms relating to clinical trial agreements and study agreements.

Jun 2008 – Jun 2010

Oct 2006 – Jan 2008

Dec 2004 – Jun 2006

Legal Counsel at Biocon Limited, (Major pharmaceutical company)

Responsible for drafting, vetting and negotiating various agreements including confidential and non-disclosure agreements, master agreements and SOW and work orders for conducting various clinical trials, supply agreements, consultancy agreements, material transfer agreements, distribution agreements, service agreements and commission agency agreements. Co-ordinating with external law firms for effective handling of company’s litigation, advising and follow up on all upcoming suits. Co-ordinating with external trademark attorneys for registrations, filings, oppositions, appeals, examination, searching journals and online databases for trademarks.

Legal Counsel at Clinigene International Limited (Clinical Research Organisation)

Solely responsible and in-charge as Legal Counsel for Clinical Research Organization and all its day to day activities and functions. Creating standard templates according to the business requirement and accepted industry standards/Good Clinical Practices/Good Laboratory Practices/HIPAA. Electronic documentation of every contract from inception till execution. Co-ordinating with various department heads in order to initiate and finalize a contract. Keeping track of contract’s expiry and renewals. Advising, drafting, vetting and negotiating various agreements including, confidential and non-disclosure agreements, international and domestic clinical trial agreements, clinical study agreements, master services agreements and related statement of works, investigator’s agreements, clinical research agreements, supply agreements, consultancy agreements, pharmacovigilance agreements, Information Technology agreements (search engine optimization), software licensing agreements, business alliance agreements, laboratory service agreements, and all other agreements that fall under the purview of commercialization of the business. Attention to detail to provisions that impact trial cost, risk, efficiency, subject injury, publication rights, insurance, reporting and intellectual property rights. Develop departmental standard operating procedures for effective functioning. Developed, coordinated and participated in educational and training programs. Managed, supervised, mentored and trained new junior staff.

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Masters in Law, University of Leicester, United Kingdom(on sabbatical for higher studies)

M/s. Singh & Singh, Trade Mark & Patent Attorneys, New Delhi, India

Responsible for handling and drafting documents for both litigation and transactional matters. Litigation work including filing suits, drafting plaints, written statements, replications, rejoinders, counter statements and various applications for infringement, deliver-up and passing-off among other trademark, patent and copyright related disputes. Duties and nature of work including representations before various judicial and non-judicial authorities. Appeared for various international beverage companies, production companies, pharmaceutical companies and corporate entities in issues arising on logo disputes, color combination disputes and other related issues. Representations before the district court and High Courts (equivalent to state Supreme Court in the US) in trademark, patent and copyright matters.

Transactional work included due diligence and drafting most corporate agreements. Various types of litigation and transactional work relating to intellectual property law including trademark, patent and copyright filing, registrations and cancellations. Worked on various US and UK assignments using search engines such as Lexis Nexis, West Law and other search engines. Advised and represented clinical research organization in drafting and negotiating various crucial terms and conditions in clinical trial agreements and management of various projects. Intellectual Property work included registrations, filings, oppositions, appeals, examination, searching journals and online databases for trademark, patent & copyright registration and other related registry work.

Sep 2003 – Dec 2004

Additional Information

Education

Professional Association

Membership

Software skills

M/s. Singhania & Co,

Drafting and vetting various types of agreements including technology transfer agreements, software-licensing agreements, licensing agreements, IT agreements, confidentiality and non-disclosure agreements, escrow agreements, distribution agreements, sales-purchase agreements, service agreements, and joint venture agreements. Drafting of various types of cease and desist notices for trademark matters. Statutory and compliance work and related documentation for trademark, patent and copyright registrations. Incorporation and registration of companies and its various foreign subsidiaries. Worked on banking matters and dealing with corresponding litigation. Also part of marketing team of the firm to bring corporate clients.

Handled various legal issues under contract law, IP commercial contracts, trademark assignment, licences, royalty agreements, software licensing agreements and other commercial contracts.

Organized seminar on “Drafting International Joint Venture Agreements”, organized by Singhania & Co., LLP in association with International Trade Centre (WTO), Geneva.

Was part of the UK delegation in Italy (March 2007) for European Working Group on Labour Law (EWL) on Affirmative Actions and Gender conducted and organised by University of Cassino, in association with EWL.

Member, organising committee, Model Lok Sabha (Equivalent to House of Commons), Bangalore University Law College.

Participated in Leicester Model United Nations (May 2007) conducted by University of Leicester.

2006 - 2008 LL.M University of Leicester, United Kingdom

2001 - 2003 B.A, LL.B (equivalent to J.D) Bangalore University, India

Model Agreements & Guidelines International (MAGI)

New Delhi Bar Association, New Delhi, India

The Indus Entrepruners, Souther California (Tie SoCal)

MS Office (Word, Excel, Power Point, Outlook),

Legal search engines (Lexis, West Law),

Applied Discovery, Relativity,

Financial Edge, EC Grants, SSRS

Diploma in Multimedia, Programming in C and C+

Diploma in Hardware and Networking



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