Manager Clinical Research

EDWARD P. MCMANMON

** ****** ******

Marblehead, MA 01945-3480

781-***-**** (H) / 781-***-**** (M)

**********@***.***

SUMMARY

Health research professional with extensive management and monitoring experience in clinical trials, project management, and epidemiology research projects.

Managed multiple clinical studies Managed/Monitored clinical sites Phase I - IV drug trial experience

Designed Case Report Forms Prepared IRB submissions Managed 3rd party vendors (CROs)

Class 2 & 3 Medical Device trials Maintained regulatory documentation Wrote Monitoring Plans

THERAPEUTIC AREAS

Parkinson’s Disease, Rare Genetic Diseases, Ophthalmology, Diabetes/Endocrinology, Cardiology, Infectious Diseases, CNS, Hematology/Oncology, Dermatology, Orthopedics, Migraine, Rheumatoid Arthritis, Osteoarthritis, Medical Imaging, Blood Transfusion Products, Anesthesiology Monitoring, Medical Devices, and Cervical Cancer Epidemiology

PROFESSIONAL EXPERIENCE

CENTOGENE, LLC, US, Cambridge, MA 1/2019 – 6/2019

Project Manager / Sr. Clinical Research Associate

Project lead for US team of CRAs employed by a German rare disease company (CENTOGENE) involved with:

Identifying and negotiating with US based central IRBs for US and Canadian rare disease epidemiology studies

Screening and qualifying US and Canadian investigators and clinical sites for rare disease epidemiology studies

Revising and editing rare disease research protocols and study related documents (ICFs) for IRB submission

Negotiating budgets with clinical sites for a series of rare disease observational epidemiology studies

CONSULTANT: Marblehead, MA 8/16 – 12/18

Regional contract and consulting assignments within the metro Boston, MA area. GCP & HIPPA recertification training, professional networking and conferences for drug & medical device trials. Multiple volunteer leadership activities (Appalachian Mountain Club).

REAL STAFFING with MEDTRONIC, Northridge, CA 11/15 – 7/16

Sr. Clinical Research Monitor (Contractor /Regional Clinical Monitor – Marblehead, MA)

Functioned as a remote regional CRM/Sr. CRA monitoring a post FDA approved Medtronic insulin pump study with a closed loop CGM system following glycemic control among enrolled Type 1 diabetic subjects

Therapeutic areas: Type 1 Diabetes, Insulin pumps, Class 3 Medical Devices

Ensured scope of work and oversight management of clinical sites followed research protocol guidelines

AEROTEK with QUINTILES, Raleigh, NC 12/14 – 1/15

Sr. Clinical Research Associate (Contractor /Regional Monitor – Marblehead, MA)

Short term contract assignment functioning as a regional Sr. CRA transitioning monitoring responsibilities between two CROs for their sponsor’s (Amgen) clinical studies

Directly involved in transitioning clinical sites involved in: Hematology/Oncology, Osteoporosis, Nephrology,, and Phase 2 and Phase 3 clinical drug trials

Maintained data management oversight of active (enrolling) clinical study sites

SYMBIO, LLC, Port Jefferson, NY 4/12 – 4/14

Clinical Research Associate (Lead) (Home Office/Decentralized – Marblehead, MA)

Employed as a regional CRA monitoring and managing clinical sites for several CRO clients.

Directly involved with clinical site evaluation visits, site initiation visits, interim monitoring visits, and study closeout visits

Assisted in managing monitoring plans & clinical sites

Trained site investigators and coordinators in study protocol procedures and study EDC systems

oMonitored & queried subject’s EDC data

oCoordinated site study supplies and their logistics with 3rd party vendors

oManaged 3rd party vendors for equipment needs and investigative drugs

oUtilized multiple clinical trial EDC systems (Inform 4.6, Axiom Go Cubed, and Symbio’s EDC systems)

oTherapeutic Areas included: Ophthalmology/Infectious Diseases (viral conjunctivitis), Dermatology (actinic keratosis, acne, psoriasis), Oncology (leukemia), for Phase 2 and Phase 3 clinical drug trials

HISTOGENICS, Waltham, MA 12/11 – 2/12

Sr. Clinical Research Associate (Contractor)

Employed as a Sr. CRA monitoring and managing clinical sites involved in a Phase II clinical trial for a biologic material (BLA) used for treating chronic cartilage degeneration of the knee

Completed Interim Monitoring visits, inventoried MRI reports, managed supply chain deliveries and updated sites on Phase III trial activities and budget allocations.

PLEIAD DEVICES, Cambridge, MA 5/10 – 12/10

Associate Project Manager / Sr. Clinical Research Associate

Employed as an Associate Project Manager/Sr. CRA monitoring and managing clinical sites involved in clinical studies for medical devices. Directly involved in osteoarthritis, ophthalmology (glaucoma), and diabetes medical device trials

Managed and approved project budgets, timelines, and 3rd party vendors

Completed Site Qualification and Initiation Visits

Monitored Clinical Sites for Interim Study Visits

Oversaw production of all project deliverables to sites by 3rd party vendors

Conducted Investigator Qualification Screening activities (phone and onsite visits) for a medical device trial

Verified project-specific site training (investigator and coordinators) and their training documentation

PAREXEL INTERNATIONAL, Waltham, MA 5/08 – 10/09

Clinical Research Associate (Lead) (Decentralized Staff)

Managed and accounted for one to three sponsor’s research protocols

Managed and monitored the progress and related issues of clinical trials at individual clinical sites

Directly involved with Rheumatoid Arthritis, Ophthalmology (diabetic macular edema), Cardiology, Oncology/Hematology, and CNS (Migraine) drug trials

Utilized web based clinical trials software (Inform 4.5 & 4.6) for subject data capture, review, and report writing

Interfaced with the sponsor, 3rd party/external vendors, and clinical sites

Maintained study databases and electronic master files (CTMS)

Managed and was accountable for one to three research protocols

Verified project-specific training (investigator and coordinators) was completed and documented

ASPECT MEDICAL SYSTEMS, Norwood, MA 12/07 – 1/08

Sr. Clinical Research Associate (Contractor – part time)

Employed as an in-house Sr. CRA reviewing paper and electronic CRFs for a large pediatric anesthesiology study

Completed data management activities related the BIS® EEG monitoring system’s clinical trials

Reviewed field (CRA) monitoring reports for correctness

CANDELA CORPORATION, Wayland, MA 2/06 – 6/07

Sr. Clinical Research Associate (Lead) / Associate Project manager

Managed the day-to-day operations of a series of clinical research studies and their sites investigating new outcomes for prototype medical lasers in development for cosmetic dermatology applications

Served as the Lead CRA with all study site responsibilities

Managed and approved project budgets and timelines

Monitored clinical sites & reviewed medical reports and charts for protocol compliance

Reviewed & prepared study protocols

Designed study CRFs

Designed CRF databases (Access & Excel)

Worked with IRBs, Research Scientists, Clinical Investigators, and Clinical sites

Completed clinical data analysis and clinical outcomes sections of final study reports

ALVAMED LLC, Waltham, MA 4/04 – 2/06

Consultant (Contractor – part time) Functioned in:

Writing & submitting sections for business proposals dealing with medical device clinical research projects

i3 PHARMA RESOURCING, at PFIZER, Inc., Groton, CT 7/04 – 12/04

Clinical Study Operations Manager (Contractor)

Employed as a clinical study operations manager (CSOM) within the Phase I clinical trials group at PFIZER GRD.

Updated Phase I trial’s registry and regulatory documents

Proofed study protocols for data management & clinical monitoring tasks

Conducted discrepancy testing of data management modules in Oracle Clinical and generated ad hoc study progress reports for current and future Phase I trials’ activities including dementia & CNS compounds

CANDELA CORPORATION, Wayland, MA 10/01 – 4/02

Project Manager for Clinical Studies

Clinical Project Manager who directed a series of clinical studies under GCP guidelines involved with multiple medical laser systems (Class II medical device) seeking FDA approval for cosmetic dermatology applications & established relational databases (Access) for data entry, clinical monitoring activities, and adverse event reporting

Monitored regional sites (Boston, MA area) for medical laser clinical studies under IDE and 510(k) guidelines

Assisted in writing clinical sections for both IDE & 510(k) FDA applications for Class II medical devices

Worked with clinical sites treating subjects, completed direct review of clinical data, and monitored research protocol compliance and safety issues by investigators

ADVANCED CLINICAL SERVICES, Cambridge, MA (Schaumburg, IL) 2/01 – 6/01

Sr. Clinical Monitor (Sr. CRA) - BIOPURE (Contractor - in house). Duties involved:

Completed clinical case review of source documents (medical charts & records) for pivotal Phase III clinical trial

Identified subject’s adverse events (AEs & SAEs) and related safety issues not previously identified

Wrote participant case narratives (hypertext linked) as part of a BLA

PERCEPTIVE INFORMATICS, Waltham, MA 9/00 – 1/01

Senior Clinical Data Manager (Contractor). Duties involved:

Resolved clinical data management issues of a diagnostic medical imaging device trial within ClinTrials software

Professional experience / Positions held prior to 2000:

Positions held include: Clinical Project Manager (PAREXEL International), SAS Programmer (Renaissance Worldwide), Project Epidemiologist (MRI, Burlington, MA), Project Director (Childhood Environmental Study - Massachusetts Health Research Institute, Boston, MA) Project Director (Barbados Eye Study – SUNY-Stony Brook, NY), Epidemiologist (KY Dept. for Health Services), Medical Technologist (VAMC), Graduate Research Assistant (Tulane SPH&TM), Peace Corps Volunteer (Yemen), and Clinical Chemist (BMC).

EDUCATION

Master of Public Health, Epidemiology, Tulane University School of Public Health & Tropical Medicine, New Orleans, LA

Master of Science, Biology, Wayne State University, Detroit, MI

Bachelor of Science, Biology (major)/Chemistry (minor), Saginaw Valley State University, University Center, MI

PROFESSIONAL DEVELOPMENT

Protection of Human Research Subjects (CITI), NIH GCP training, Overview of GCP & Human Subjects Protection (VA), Medical Device GCP Overview (Barnett International), Wilderness First Aid (SOLO), PAREXEL/Barnett International training courses in: Clinical Data Management, Clinical Project Management, Clinical Site Monitoring, Drug Development and FDA Regulations

TECHNICAL (Software) SKILLS

Medidata RAVE, Inform 4.6, Oracle Clinical, ClinTrials, Axiom EDC systems(2), Siebel CTMS, Adobe Acrobat - Professional, MS Office Professional (Word, Excel, Access, PowerPoint, & Outlook), Windows 7, 8.1, & 10

PROFESSIONAL MEMBERSHIPS

American Society of Clinical Pathologists, Chemist

Association of Clinical Research Professionals, Member

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