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Global Study Management Monitoring & Site Audits Resource Management

Data Review Performance Management Budgetary Control Protocol Development

         Bilingual (English & Portuguese) and senior-level Clinical Research Specialist with substantial background in pharmaceutical industry and proven talents in global leadership, budget administration, resource management, data review, training, team motivation, and performance management.

         Extremely well-versed in R&D operations from target discovery to pre-clinical and clinical development phases I-IV; specialization in oncology and cardiovascular drug development.

         Adept at leading cross-functional teams throughout clinical studies with full accountability for project management, regulatory compliance, and cost containment.

         Extensive talents in developing clinical development plan, managing vendor relationships, allocating resources, ensuring patient safety, and building cohesive teams.

         Proficiency in site selection, study initiation, and study execution; possess advanced knowledge of GCP/GMP and regulatory processes.

• Optimize clinical program performance by building unified relationships with key stakeholders.

Celgene Corporation, Summit & Basking Ridge, NJ, 2007 to Present

Strategic Program Director, Investigational Material Supply Chain (2012 to Present)

         Direct Program Level Planning (PLP) teams in devising integrated cross-functional strategy and implementation plans to ensure continuous supply of investigational product.

         Control budgets, timelines, risks, and stakeholder relations across multiple complex projects.

         Manage, mentor, coach, and direct program managers, and effectively join forces with Clinical Operations to optimize clinical trial efficiency

         Communicate with governing bodies, standardize PM best practices, and ensure precise alignment between project strategy and tactical execution of supply plans.

         Forge, nurture, and maintain Celgene/CRO partnership to expedite study start-up.

         Strategically manage IMSC (investigational material supply chain) to minimize waste by continuously monitoring supply inventories and patient enrollment; achieved goals two months ahead of target.

         Optimize high-value compounds supply by communicating effectively with key stakeholders.

         Partner with Tech Ops and Alliance Management regarding collaborations for drug exchange to facilitate and optimize demand planning.

         Formalize IMSC compound strategy to increase visibility of short and long-term planning for senior management.

Clinical Research Scientist, Clinical Research and Development (2010 to 2012)

         Partnered with physician throughout project phases and functional areas encompassing clinical operations, data management, statistics, drug safety, and regulatory compliance.

         Prepared detailed investigator brochures, regulatory submission documents, clinical study report, and clinical study protocols.

         Contributed to establishing project budgets, reviewing summary information (i.e. safety, primary efficacy variables, laboratory data), development planning, and clinical program administration.

         Presented information at investigator meetings and served on multiple corporate committees.

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Senior Study Manager, Clinical Operations (2007 to 2010)

         Led cross-functional study team throughout clinical operations including formulating study management plan, determining and tracking budgets, assembling training materials, compiling regulatory package, approving investigative sites, and fostering cooperative relationships with affiliate offices.

         Instructed study team in protocol, set up TMF, managed study vendors, approved vendor invoices, managed site payments, and diligently monitored GCP/ICH compliance across sites.

         Clarified study team contact roles and responsibilities, enforced adherence to monitoring plan, supported risk management efforts, and played an integral role in creating user management tool and executing UAT.

         Supervised timely distribution of IND safety report to investigators and study team members.

         Delivered CRA training, held regular investigator meetings, obtained regulatory approvals and appropriate insurance, and authorized investigational product shipment to investigational sites.

         Helmed clinical monitoring to ensure quality of data, swiftly resolved issues with clinical team from patient medical management, conducted CRA meetings, and addressed site issues uncovered during audits.

         Flawlessly orchestrated study close-out including case book review, archiving, and reconciliation of study budget, payments, and TMF.

Manager, Clinical Operations (2004 to 2007)

         Spearheaded full-scope clinical studies including direction of team members, CRO selection, protocol development, CRF preparation, investigator selection and meetings, site management, budgetary control, vendor selection, and clinical study report generation.

         Reviewed ongoing summary data pertaining to patient safety, primary efficacy variables, and laboratory data with constant attention to quality control and consistency of medical data.

Aventis Pharmaceuticals, Bridgewater, New Jersey, 2002 to 2004

Medical Research Associate, Cardiovascular/Thrombosis (2003 to 2004)

         Championed clinical research activities for assigned studies while ensuring constant adherence to GCPs, internal SOPs, and safety reporting procedures.

         Extensively participated in investigator selection, CRF design, protocol development, and budgeting tasks.

Work Leader (Regulatory Compliance) / Clinical Trial Lead, Cardiovascular/Thrombosis (2002 to 2003)

         Actively recruited potential investigators for clinical trial, procured clinical supplies for site, and seamlessly coordinated correspondence among sites including protocols, newsletters, and safety updates.

         Set up and maintained investigator database and trial master file, assembled investigator and regulatory binders, and tracked regulatory documentation such as 1572s and signed protocol.

         Documented IRB meetings, input data into IMPACT system, processed invoices, administered grant payments, and monitored site enrollment.

Consumer Product Testing Co., Inc., Fairfield, New Jersey, 1995 to 2002

Clinical Projects Manager (1999 to 2002)

         Assigned clinical projects to team members, maintained master schedule of projects, prepared informed consents for study trials, handled IRB submissions, and oversaw data management.

         Trained and mentored CRAs on standard operating procedures, GCP guidelines, and other regulatory criteria; improved staff performance by assembling training manual for Clinical Department.

         Promoted from initial roles as Clinical Research Associate / Group Leader (1998 to 1999) and Clinical Research Associate / Group Leader Assistant (1995 to 1998) based on exemplary performance.

MBA, Capella University, Minneapolis, MN

BA, Forensic Psychology, John Jay College of Criminal Justice, New York, NY

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DATE

HIRING AGENT NAME

TITLE

COMPANY NAME

ADDRESS

CITY/STATE/ZIP CODE

Dear__________________:

I am currently seeking a challenging career opportunity in a clinical research capacity and am submitting my resume for your review. In advance, thank you for your time and consideration.

I am excited to build a rewarding career with your organization, and can offer cross-functional leadership experience in all aspects of clinical trial management including site selection, budget administration, team direction, and supplier management. My considerable scientific acumen and collaborative work ethic also enables me to effectively interface with scientists, physicians, and regulatory agencies in order to lead compliant and quality-driven clinical research operations.

To complement my professional background, my academic achievements include an MBA and a Bachelor s in Forensic Psychology.

Currently, as Strategic Program Director of Investigational Material Supply Chain at Celgene Corporation, I am charged with ensuring a continuous supply of investigational products at minimal cost, with maximum efficiency, and in alignment with rigorous quality parameters.

As this is just a sampling of my job history, please refer to the accompanying resume for additional experience. I look forward to speaking with you personally, as I believe the sum of these aforementioned reasons will prove me to be an asset to (INSERT NAME OF ORGANIZATION). Thank you for your consideration.

Sincerely,

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