Clinical Research Operations Manager

Joseph Melillo Sr.

Hopewell, New Jersey *****

609-***-**** - ********@*****.***

Professional Summary

Experienced Leader with over twenty-five years of expertise developing strong partnerships in pharmaceutical and clinical research industries, leading operational teams, designing and integrating data systems and datasets as well managing client and vendor relationships. Proven operational delivery, problem-solving and organizational skills, resulting in the co-founding of three organizations with tremendous growth and success, all of which were acquired.

Accomplishments

Co-founded and established multiple highly successful organizations through acquisition by maintaining an excellent performance history in growth, client satisfaction and expanding client footprint.

oPRS was acquired by Ventiv Health (now Syneos) in 2005: Acquisition (press release).

oPharmFlex was acquired by Snyder communications: Acquisition (press release).

Established an excellent reputation as a strategic leader and operations manager, based upon innovative solutions, integrity, performance, and results. Managed successful partnerships with many leading pharmaceutical organizations and vendors.

Established a highly successful team from startup of two employees through acquisition to a team of over one hundred people while maintaining a highly desirable work environment and culture.

Designed and managed an industry-leading sales and marketing analytics platform by creating an innovative solution to data integrity challenges with prescriber and patient data.

Employment History

Fortrea Drug Development Princeton, New Jersey, US – Nov 2015 – Present

Senior Manager Key Accounts Client Services

Leads cross-functional teams responsible for proposal, budgeting, operational delivery, and contracting with Fortrea's largest accounts.

Leads large cross-functional teams with strategic and/or highly complex opportunities and initiatives.

Accountable for the preparation of high quality and accurate proposals and presentations in accordance with agreed strategy and sponsor expectations under the pressure of changing timelines.

Leads cross-functional team of medical and operational professionals to produce operational plan for clinical research, including subject-matter experts across scientific and business functions within the organization.

Organizes and leads (and/or coaches’ others) on the strategic and operational calls related to the opportunity/account working across the organization in matrix environment across multiple time-zones.

Identifies and is accountable for driving ways to improve the efficiency and quality of processes and the resulting deliverables, influencing key stakeholders as applicable.

Responsible for creation, negotiation, and finalization of clinical study budgets, contracts, initial operational plans, and strategies.

Liaises with third party vendors’/vendor managers for provision of quotations and/or information where required.

Inventiv Health (Syneos), Somerset, New Jersey, US – Aug 2005 – Apr 2009

Vice President Strategic Information

Responsible executive representing operational and IT teams in executive governance meetings, accountable for metrics.

Managed a highly effective team of over one hundred employees with an exceptional atmosphere and coordinated team approach in data management, patient assistance, and information services.

Managed vendor performance, data quality, budgets, contracts.

Project Management Leader for integration and growth initiatives.

Managed customer relationships, overseeing project management and client senior executive relationships to satisfy governance and compliance with operational project plans.

Responsible for design and growth of complex data management systems, working through a team of programmers to meet audit ready demands of pharmaceutical regulatory and compliance.

Responsible for business development, demonstrating company capabilities as a lead operational and information management subject-matter expert.

Responsible for strategic Information services planning and integration of new products and capabilities.

Pharmaceutical Resource Solutions, Horsham, Pennsylvania, US – Jan 2000– Aug 2005

Managing Partner

Cofounder PRS, sales, and marketing support and regulatory compliance provider to the pharmaceutical industry.

Designed and implemented an industry-leading data processing system satisfying regulatory and marketing needs for client sales teams.

Business development key stakeholder responsible for increased revenue and profit margin from launch through post-acquisition with growth rate over fifty percent each year.

Project Manager for multiple client contracts.

Managed client accounts and relationships successfully.

Established and managed an operational team from three employees at inception to over fifty within four years.

Developed and launched complex information system fully integrated with pharmaceutical partners, satisfying multiple stakeholders changing requirements.

PharmFlex LLC, Malvern, Pennsylvania, US – Aug 1992– Mar 1999

Minority Owner Director Information Services

Operations Director at PharmFlex, a leading contract sales organization in the pharmaceutical industry. Typical contracts ranged between $3M - $10M annually. Clients included Wyeth, Abbott, Janssen, Lilly, Pharmacia/ Upjohn, Endo, Hoechst.

Designed and implemented innovative call reporting and sample accountability solutions, including weekly activity reporting and sample compliance systems responsible for several thousand pharmaceutical sales representatives across the United States.

Led business development presentations, Key subject-matter expert responsible for IT/IS, operational management, regulatory, compliance audits, and the operational budget.

Created and managed RFP process as coordinator of sales and marketing team.

Managed vendors for data, printing, shipping, labelling, and sample supplies

Managed sales force territory alignment, contract sales representative recruitment efforts, and compensation programs.

Designed incentive programs to achieve sales and marketing goals.

Wyeth Labs, Great Valley, Pennsylvania, US – Oct 1991– May 1994

Senior Analyst Information Services

Internal consultant responsible for sales and marketing reporting systems.

Created data integration solutions to provide consolidated reporting within corporate family.

Worked with vendors to integrate external technologies with sales support systems.

Highly effective liaison between business units and Information Services department.

Pittsburgh Business Consultants, Pittsburgh, Pennsylvania, US – May 1990– Oct 1991

Programmer/Analyst

Business consultant responsible for data integration and implementation projects in manufacturing industries.

Converted Burroughs mainframe systems to IBM 390 platform.

Recoded legacy programs to suit current best coding standards.

Designed interfaces to support transition of systems.

Education

Bachelor of Science - Decision Sciences

Rider University – Lawrenceville, New Jersey

Master of Business Administration, December 2024

Rider University – Lawrenceville, New Jersey

Contact this candidate