Project Manager Management

CHRISTOPHER CONKLIN

*** ******* ******, **** **********, PA 19034

610-***-**** *****.*******@*****.***

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SUMMARY

I have a strong background in Clinical Operations having worked in variety of clinical trial execution functions for nearly the past ten years. My strong foundation in Organizational Development has allowed me to be an effective people manager and contributor to development of process. I am also Subject Matter Expert at Merck for a number of functions in the Study Planning, Initiation, Program/Study Planning and Management space. I've made significant contributions to the conduct of clinical trials at Merck through the participation in work streams dedicated to the integration of Legacy Merck & Schering-Plough clinical trial operations organizations as well as several subsequent process development sub-teams post-integration.

I have contributed to large-scale systems implementation for a clinical trial tracking and simulation application and have deep knowledge and understanding of the patient recruitment provider and Site Management Organization marketplace. I have conducted protocol feasibility and met patient recruitment challenges across a wide variety of therapeutic areas and have been responsible for timely enrollment as a sponsor, patient recruitment service provider, and coordinator.

EXPERIENCE

Merck & Co., North Wales, PA Feb. 2008 – Present

Manager, Global Trial Optimization

Therapeutic Area Lead for Respiratory & Immunology. Responsible for protocol feasibility assessment and recruitment and retention planning for all trials within the TA. Managed three Global Trial Optimization Specialists in support of these efforts

Liased with an Investigator Consultation Network and Informatics Analysts to provide operational insight into protocol design and to build models to predict clinical trial enrollment

Supported the business case development, pilot & ultimate implementation of a web-based application to track, project and model clinical trial enrollment

Served as a member of the Site Management Organization Sourcing Management Process (SMP) team. Contributed to a comprehensive marketplace evaluation and ultimate selection of preferred providers

Served as Subject Matter expert for a Study Planning and Initiation subteam supporting the integration of Merck and Schering-Plough and also for several workstreams in the Program and Study Planning and Management space post integration including: patient recruitment and retention, enrollment tracking, site validation, and SMO implementation. Authored Development Procedures and Job aids for processes within those areas.

Global Trial Optimization Specialist

Responsible for protocol feasibility assessment and development of patient recruitment and retention plans for all trials in a number of development programs across a number of TAs including: diabetes, cardiovascular, neurology, immunology and respiratory

Responsible for providing benchmarking for developing clinical trials and programs resulting in realistic and aggressive cycle times. Worked with Informatics group to provide and present clinical trial modeling and simulation

Identification of geographic recommendations and provide guidance for site selection

Identification and management of SMOs and patient recruitment vendors to improve rates of enrollment

Served as a member of the patient recruitment Sourcing Management Process (SMP) team. Contributed to a comprehensive marketplace evaluation and ultimate selection of preferred providers of patient recruitment services.

Currently serving as member of Study Planning and Initiation taskforce during the integration of Merck and Schering-Plough

Lead initiative to pilot a web-based clinical trial forecasting, modeling and simulation tool. Has since been approved for deployment across the enterprise

Lead or contributed to a number of patients recruitment initiatives including: Screening Center, Search Engine technology for the identification of study candidates & enrollment modeling and simulation

George Washington University Fall 2011 –

Adjunct Professor – Department of Clinical Research Administration

Instructor for Graduate Course entitled "The Clinical Research Industry.

Acurian Inc., Horsham, PA Sept. 2006 – Feb. 2008

Project Manager – Patient Recruitment

Responsible for on time delivery of all patient recruitment, enrollment and retention activities for assigned projects.

Successfully managed recruitment campaigns for16 protocols in the following indications: Insomnia, Obesity, Hypercholesterolemia, Overactive Bladder, Diabetes, Diabetic Foot Ulcer, Cervical Dystonia, and COPD

These campaigns produced over 1200 randomized patients for sponsors and over $6M in revenue for the company

Designed program/protocol specific recruitment campaign tailored to the needs of the sponsor

Duties include: selection of recruitment tactics, development of pre-screening questionnaire, design of patient recruitment materials, IRB submissions, management of call centers and other vendors, vendor and customer training, campaign tracking and reporting.

Led dedicated investigative site services teams for each protocol in order to liaise with study coordinators and monitors

Determined and managed project budgets, provide revenue forecasting

Johnson & Johnson Pharmaceutical Research and Development Jan. 2005 – Sept. 2006

Manager, Clinical Supplies – Customer Relations Management Group

Responsible for the global coordination of the manufacturing, packaging, labeling and distribution of all clinical supplies for three compounds in full development

Liaised with CSU customers to establish and maintain accurate long-term forecasts of clinical supplies needs and to advise them on clinical supplies packaging design

Developed a trial specific supply plan for each trial together with the customer

Served as a member of the clinical team to ensure that there are adequate levels of supplies and that there are no interruptions in the supply chain

Served as a member of the Chem-pharm team to assist with the coordination of bulk drug manufacturing, testing and release

Determined the distribution strategy for each trial and worked closely with distribution vendors

Assisted with the development of IVRS system specifications, managed clinical supplies inventory using IVRS tools

Developed and provided budget, out-of-pocket expenses, FTE and timeline forecasts

Tracked spending vs. budget

Beacon Bioscience, Inc., Doylestown, PA Sept. 2004 – Dec. 2004

Project Manager

Served as Project Manager for medical imaging CRO, providing product development services to pharmaceutical, biotechnology and medical device clients. Served as primary point of contact for clients

Responsible for the delivery of project specific requirements within timeline and budget

Responsible for the development of a project specific Imaging manual and Procedure Manuals

Ensured clear communication with clients, study centers, and CRA

Monitored offsite assessments and blinded reads

Responsible for supervision of 3 Medical Imaging Specialists and 2 Project Assistants

Fox Chase Cancer Center, Philadelphia, PA Feb. 2002 – Sept. 2004

Research Coordinator – National Cancer Institute’s Cancer Information Service

Research coordinator for the Atlantic Region of the National Cancer Institute’s Cancer Information Service. Specializing in health communications, cancer control, and behavioral research

o Primary responsibilities included: site monitoring, protocol development, study implementation, literature review, assembly of research grant proposals, data analysis, and compliance with IRB policies and procedures.

Member of the Atlantic Region management team

o Primary responsibilities included: strategic planning, program and staff development, and daily operations.

Member of Informed Consent Monitoring Committee for the Fox Chase IRB

Atlantic Region’s Media Liaison

o Assisted with network-wide media campaigns and promotion efforts to promote the CIS

Research Assistant – Psycho-oncology Program

Research Assistant for Dr. Sharon Manne on a number of NCI-funded research projects including:

o Psychological Intervention for Ovarian Cancer Patients

o Colon Cancer Screening for Siblings of Colorectal Cancer Patients

o Couples Coping With Cancer

o Informed Consent for Microsatellite Instability Testing.

Managed implementation of studies, monitored study sites, was responsible for patient recruitment, assisted with instrument development, data management, and IRB compliance

Community Centered Treatment, Inc., Springhouse, PA Nov. 2000 – Jan. 2005

Adolescent Counselor

Collaborated with the Montgomery County Office of Juvenile Probation and the Office of Children and Youth to provide individual counseling to adolescent males.

Central Montgomery MH/MR, Norristown, PA June 2000 – July 2001

Family-Based Therapist

Provided individual and family counseling in conjunction with a family therapist.

Developed treatment plans and operated an emergency on-call service.

EDUCATION

M.S. Organizational Development and Leadership

Philadelphia College of Osteopathic Medicine – Philadelphia, PA

2004 - 3.8 G.P.A.

B.A. Psychology

Beaver College (Now Arcadia University) – Glenside, PA

2000 - 3.3 G.P.A. - Member of Psi Chi

PMP Certification – Project Management Institute

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