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Clinical Operations Manager with experience in implementing and leading diverse multi-disciplinary teams through all life-cycle phases for complex research and development projects. Results oriented with proven record in effectively managing small and large complex clinical programs within established timelines and budget. Over 12 years of experience with outsourcing both large and small clinical programs and oversight of CROs and external vendors. Great multi-tasker, natural problem solver, team worker and project leader that inspires others by example and continuously delivers on challenging goals with high quality and attention to detail. Recognized by peers and upper management for exceptional performance through promotions, and increased responsibility.
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Global LeadActelionMount Laurel, Nj, Us -
Global LeadActelion Jun 2017 - PresentGreater Philadelphia Area -
Global Trial Manager On Assignment With ActelionAerotek May 2016 - Jun 2017Cherry Hill, New Jersey -
Clinical Program Manager On Assignment With Teva PharmaceuticalsPlanet Pharma Jun 2015 - Apr 2016Frazer Pa• Inspection Readiness activities for Respiratory Therapeutic Area Review Trial Master Files to ensure documents are present and identify risks with missing and incomplete documents Participate in Mock inspections and prepare for FDA Inspections Participate in FDA inspections• Lead Clinical program manager on Phase I Pediatric Respiratory trials Manage global, virtual cross functional teams, including outsourcing activities from protocol to database lock Review and provide feedback on synopsis, protocol, feasibility, study documents, site selection, etc. • Manage with meeting planners Large Phase III Global Investigator meetings for Respiratory studies. -
Senior Gcped Operations ManagerAstellas Pharma Jan 2012 - May 2015Greater Chicago AreaManage Phase I assigned clinical studies within established timelines and budget. Line Manager for approximately 8 External Contract Field CRAs Assist in develop a training curriculum for Clinical Research Associates to ensure consistent expectations across GCPED studies Review and approve training records, monitoring reports, time reports and expense reports for monitors. GCPED representative on process improvement initiatives. Mentor CRAs and Study Managers
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Manager Operations, GcpedAstellas Pharma May 2011 - Dec 2011Greater Chicago AreaManage Phase I assigned clinical studies within established timelines and budget. Perform monitoring responsibilities as needed.
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Clinical Program ManagerAbbott Products, Inc (Formerly Solvay Pharmaceuticals,Inc) Feb 2004 - Feb 2011Marietta GeorgiaManaged Testosterone Gel Program in hypogonadal males (highest priority in US business strategy). Lead CPM for Oral Testosterone Program. Lead CPM on the team that successfully internalized Monitoring and Project Management of the Phase IV Prometrium® Secondary Amenorrhea Program.Managed Phase IV Estrogel® program for Menopausal Symptom and Vasomotor Symptom Relief (90 sites 330 patients) and providing oversight of CRO and external vendorsManaged and provided oversight of CROs (including utilization of full service providers) and external vendors for assigned Phase I studies in multiple therapeutic areas Provided internal management, coordination and monitoring of Phase I studies across multiple Global Functional teams in a virtual environment within multiple therapeutic areas and routes of dose administration.Initiated Phase I weekly teleconferences with cross functional teams both internal and CRO, to improve communication and transfer of study related information.Created a Phase I Global Monitoring Plan to use within the Solvay/Quintiles Alliance for process improvement. Use of monitoring plan was expanded to all Phase I studies across all CROs.Member of CPM Phase I working team for global process improvement and standardization internally and within the Solvay/Quintiles Alliance.Participated as a subject matter expert in the creation and implementation of a new outsourcing and oversight GOP.Led initiative within the Solvay/Quintiles Alliance to optimize the data collection and query resolution process with Quintiles Data Management Team in South Africa.Member of Solvay/Quintiles Alliance Phase I Biometrics Manual and Alliance Records Management Manual development teams.Advisor on Phase I multi-site (Germany and Sweden) for severe Parkinson’s patients.Trained and mentored CRAs, CPMs, and Clinical Scientists.
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Senior CraSolvay Pharmacueticals Oct 2001 - Feb 2004Marietta GeorgiaProvided clinical operational leadership in Phase I studies across multiple therapeutic areas. Managed CRO activities for assigned trials. Requested and reviewed RFPs.Facilitated the development of study related documents (study protocols, amendments, ICFs, CRFs).Member of Phase I Data Standardization team which developed data collection standards for Phase I studies.Reviewed and approved monitoring reports. Primary clinical operations liaison between Sponsor and Contract Research Organization personnel. Mentored new members of the Clinical Pharmacology department on operational aspects of running Phase I studies.
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CraSolvay Pharmaceuticals Feb 1999 - Oct 2001Marietta GeorgiaManaged assigned investigational study sites and performed on-site quality reviews of study related documents. Implemented kick-off meetings between cross functional teams across Solvay and Quintiles for Phase I studies. Provided input in the development of protocols and protocol amendments. Primary liaison for CRO CRAs. Performed pre-site selection visits, initiation visits, site training, clinical conduct visits, interim monitoring visits and study close-out visits.
Barbara Parker Skills
Barbara Parker Education Details
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Keller Graduate SchoolBusiness/Project Management -
Biology
Frequently Asked Questions about Barbara Parker
What company does Barbara Parker work for?
Barbara Parker works for Actelion
What is Barbara Parker's role at the current company?
Barbara Parker's current role is Global Lead.
What is Barbara Parker's email address?
Barbara Parker's email address is ee****@****msn.com
What is Barbara Parker's direct phone number?
Barbara Parker's direct phone number is +177082*****
What schools did Barbara Parker attend?
Barbara Parker attended Keller Graduate School, Rutgers University - Camden.
What are some of Barbara Parker's interests?
Barbara Parker has interest in Football, Exercise, Nascar, Home Improvement, Shooting, Reading, Gourmet Cooking, Sports, Hockey, Watching Hockey.
What skills is Barbara Parker known for?
Barbara Parker has skills like Cro, Clinical Trials, Clinical Research, Oncology, Gcp, Clinical Monitoring, Trial Management, Strategic Partnerships, Outsourcing, Ich Gcp, Clinical Development, Regulatory Affairs.
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