Dedicated Clinical Research Operations Manager eager to contribute talents and background toward supporting a dynamic organization in achieving goals and objectives.

 

 

         Proficiency in project and personnel management, budgeting, forecasting, and quality control.

         Significant experience in planning and coordinating successful clinical trials with a constant eye on ICH/GCP compliance and adherence to SOPs.

         Sharp critical thinking abilities and adept at risk/problem identification and mitigation.

         Leverage exemplary therapeutic and operational expertise to optimize trial design and execution.

         Considerable strengths in developing clinical trial protocols. 

         Extensive experience in Neurology and Immunology (Multiple Sclerosis, Psoriasis, Crohn s Disease).

 

 

Genzyme, Cambridge, MA, 2010 to Present

Senior Director, Clinical Research / Therapeutic Area Liaison, MS & Immune Diseases

• Spearhead operations and projects within MS and Immune Diseases TA (Therapeutic Area) while concurrently serving as primary point of contact to TA Group Head for all Clinical Research Operations.
• Demonstrate exceptional versatility in seamlessly managing budget, resources, quality control, and regulatory compliance.  
• Direct, supervise and manage personnel while actively collaborating with partner lines to achieve established goals and objectives.

 

Biogen Idec, Maidenhead, UK & Cambridge, MA, 2001 to 2010

Global Clinical Operations, Neurology TA / Associate Director, Clinical Operations        (2008 to 2010)

• Directed program operations to ensure clinical studies adhered to timeline and budget parameters, SOPs, regulatory criteria, ICH/GCP guidelines, and TA strategies and goals.  
• Applied dynamic leadership talents toward managing cross-functional clinical development teams.
• Analyzed and identified clinical program risks, devised and initiated mitigation plans, and played an integral role in development and execution of clinical development plan (CDP).
• Presented program status and strategies to R&D, corporate leadership, and external partners.
• Frequently reviewed staffing needs and ensured ensure adequate resources were assigned to achieve program deliverables.

 

Staff Associate (Senior Manager), Clinical Data Management     (2007 to 2008)

Acting Neurology Line Manager, Clinical Operations     (2007 to 2008)

         Directed and facilitated training and coaching for associates, senior associates, Data Management, and administrative personnel.

• Represented Clinical Data Management and Clinical Operations in cross-functional and enterprise-wide project initiatives.
• Orchestrated offshoring and outsourcing strategy for Data Management Department, served as primary liaison to offshore vendor, and held accountability for onsite quality assurance and audits. 

 

Continued

 

 

Professional Experience continued                                                               Yyyyyy x. yyyyyy C Page 2 of 2

 

• Performed forecasting to determine required budgets and resources for offshore projects.
• Monitored and evaluated offshore vendor performance inclusive of metrics, timelines, budgets, resources, and deliverables across all studies.
• Conducted in-depth problem solving to swiftly resolve financial or operational issues which impacted budgets, contracts, deadlines and deliverables.
• Identified risks and proactively assembled effective mitigation plans.

 

Clinical Trial Manager, Neurology TA    (2006)

• Assessed feasibility of studies to determine probability of success for each trial, critically considering design, size, location, and patient population.
• Cooperated with Medical Director to design and establish clinical trial protocols consistent with CDP.
• Co-developed and managed ongoing data review which defined study data variables for tracking purposes to ensure correct patient recruitment, detection of data trends and attainment of study objectives.
• Provided valuable input into vendor selection and determined clinical vendor specifications.
• Steered full-scope clinical trial spanning study set-up, budgeting, GCP and SOP compliance, trial execution, and vendor management.

 

Clinical Data Manager / Clinical Data Program Manager           (2001 to 2006)

         Handpicked to set up Maidenhead s International Data Management Department in 2003.

         Held a significant role in successfully filing Tysabri with FDA/EMEA.

• Led cross-functional data team in data management processes from protocol inception until release of data for statistical analysis for drug program.
• Compiled and provided quality data for potential ISS and ISE CSRs and phase IV studies.
• Employed strong prioritization skills to ensure and enforce alignment with timelines, contracts, regulatory requirements, and quality control/assurance.
• As Clinical Data Manager, organized and administered personnel training and development, and achieved excellent staff retention levels through motivation, coaching, and recognition of outstanding performance; recruited and hired contract, temporary and permanent staff as needed.
• Diligently ensured consistent compliance by department with all Clinical Data Management practices, processes, and SOPs.

Prior Background:

 

Clinical Designer / Developer, PhaseForward Inc., Waltham, MA, 2000 to 2001

Senior Clinical Data Manager, Novartis Pharmaceuticals, Summit, NJ, 2000

Clinical Data Manager, Kendle International Inc., Old Lyme, CT, 1998 to 2000

Clinical Data Manager, Parexel International, Waltham, MA, 1997 to 1998

Clinical Laboratory Technologist, Center for Blood Research, Boston, MA, 1996 to 1997

 

 

Bachelor of Science in Biology, Concentration in Biomedical Sciences  

Framingham State University, Framingham, MA, 1996

 

 

Clintrial, Business Objects, SQL, Oracle Clinical 4.3, Microsoft Office (Word, Outlook, Excel, PowerPoint, Access), Microsoft Project, Scanning Power & Visual Basic, C Programming, Lotus Notes, Macintosh O/S