Sharon R. Email and Phone Number

Provide operational oversight of clinical trials from design and implementation through study close-out and final data analysisEnsure that all projects are completed on time and within budget, conducted and monitored in accordance with International Council for Harmonization’s (ICH) Good Clinical Practices (GCPs), Food and Drug Administration (FDA) and adhere to all relevant regulationsParticipate in and contribute to cross-functional strategic discussionsLead, motivate and mentor the Clinical Operations team including in-house and contract Clinical Research Associates (CRAs), Clinical Operations Specialist (COS), Clinical Trial Assistants (CTAs) and Quality Assurance (QA) personnelPerform personnel performance reviews, coaching, career development and corrective action plansDevelop, manage and report key study metrics to upper level managementContribute to development and oversight of study budgetsCreate and implement Standard Operation Procedures (SOPs) for Clinical Operations departmentImplement and train contract and in-house CRAs on risk-based monitoring guidelinesContribute to the authorship of clinical study protocols, electronic and paper Case Report Forms (CRFs) and guidelines, Informed Consent Form (ICF) templates, Study Monitoring Plans (SMPs), Study Operation Plans (SMPs) and other study related documentsEnsure integrity of clinical data accuracy, accountability and documentation is consistent with ICH/GCPs and SOPsResponsible for key deliverables, timelines, personnel resources, clinical trial logistics, investigational sites and consultantsVerify compliance with all state and federal regulations and company policies

Manage all aspects of clinical studies and associated risks to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines .Manage and train clinical staff, including in-house and contract Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs), and 3rd party vendors.Provide leadership for the operations of the clinical department.Write, review and revise study protocols, internal and external study related resource documents, and SOPs.Develop and validate study databases.Prepares and/or assists in preparation and oversight of study budgets and timelines.Analyze and provide insight on matters of patient care and safety, study design and study conduct issues.Develop and direct clinical monitoring plans and study monitoring priorities.

Manage study timelines and critical path deliverables.Collaborate with upper management on study design and protocol development.Write and review study protocols, ICF templates, and all study materials.Generate and manage study metric reports and present comprehensive study updates to upper management.Train and supervise clinical personnel.Review CRA monitoring reports for accuracy and completeness.Implement Corrective Action Plans when necessary, and ensure resolution of outstanding issues.Manage all electronic and paper Trial Master File documents.Write and review Standard Operating Procedures.Manage study sites and ensure compliance with study protocol, GCP, and ICH Guidelines.Design electronic study database and generate validation specifications.Review and verify data listings.Provide data and generate tables for study publications.

Develop new study objectives, assist in writing and reviewing study protocols.Create study specific supplementary materials including Informed Consent Form templates, Study Operation Manuals and Case Report Form Completion Manuals.Establish and maintain Trial Master Files.Function as primary contact for all study sites.Conduct Site Initiation Visits.Perform Monitoring Visits (100% Source Data Verification), complete Monitoring Visit Reports and Follow Up Letters.Ensure sites are conducting research studies according to protocol, GCP and ICH guidelines.Create and maintain spreadsheets to track study metrics and supplies.Perform remote database reviews, issue and close out queries as necessary.Identify cases and controls for analysis.Identify and define confounders in analysis datasets.Manage database locks.Assist in the development and review of Clinical Department SOPs.

Accountable for simultaneous, overall management of multiple clinical research studies from protocol development through final CSR.Detailed understanding of critical path, deliverables to clients, and the robust planning required thereof, to ensure success in quality execution of clinical research studies.Contribute to strategic outsourcing decisions and strategies for identifying CRO vendors.Accountable for review of final contracts and transfer of obligations to ensure scope and budget match prior to budget sign off.Supervise performance of 3rd party vendors to ensure deliverable expectations are met within projected timelinesPrimary operational contact for client and vendorsPro-actively identify and resolve timeline, scope and resource issuesDevelop and maintain comprehensive status reportsEnsure all team members are adequately trained and aware of client expectations and protocol specifics

Function as primary contact with Sponsor companies. Coordinate all aspects of study management. Full responsibility to ensure that study objectives are achieved and deliverables meet target timelines and are within budget. Manage the project team including direct line management of study staff. Conduct interviews, performance evaluations and mentor Senior Clinical Research Associates, Clinical Research Associates, Clinical Study Associates, Research Associates and administrative staff on study team. Perform feasibility assessments to determine research site, staff allocation and costing needs for study protocols. Contribute to study project bid defenses through preparation of clinical operation timelines, costing estimates and protocol review. Represent Clinical Operations Department at bid defense meetings by presenting Sponsor and study specific recommendations for clinical operation processes and procedures. Ensure that all studies are conducted according to Good Clinical Practices and International Standards of Operations.

Responsible for managing all aspects involved in planning, executing and conducting international Phase IIIb/IV Osteoporosis trials including timeline generation and management, reviewing Contract Research Organization proposals, conducting CRO audits and contract negotiations. Integrated and supervised all interdepartmental and vendor team leaders and activities. Supervised investigator recruitment, evaluation and site audits.Performed project risk assessments and developed contingency plans.Provided regular study status updates to senior management. Managed and mentored CRAs and Senior Clinical Research Assistants. Supervised and tracked timeline adherence and milestone achievement. Coordinated interdepartmental and vendor team activities. Monitored and maintained study budget and vendor invoices.

Supervised the development and assisted in the writing of Phase III study protocols, Informed Consent Forms, data review guidelines, edit checks, regulatory documents, Case Report Forms and CRF completion guidelines. Evaluated CRO proposals and assisted with contract negotiations.Supervised vendors and interdepartmental team progress on meeting study milestones in accordance with timelines. Managed study budgets, contract/budget variance, reconciled vendor pass through costs and approved/denied invoiced vendor services.Developed materials and presented at investigator meetings and CRO CRA training sessions in the U.S. and South America. Interacted with internal and 3rd party data management, analysis programming and statistics department as required. Organized and participated in site selection, site initiation and study start up procedures in the U.S. and South America. Performed site initiation visits, interim monitoring visits and close-out visits. Monitored sites' regulatory binders, performed drug reconciliation and return and conducted 100% source data verification with CRF data. Co-monitored and mentored CRAs, reviewed monitoring reports, provided performance feedback and identified situations that warranted Corrective Action Plans.

Assisted with the development of Phase I and III study protocols, ICFs and CRFs. Reviewed CRO proposals and participated in CRO supervision and evaluation. Coordinated vendor meeting logistics and presentations. Participated in site selection, site initiation meetings and study start up procedures. Co-monitored European sits' regulatory documents, study drug inventory logs, source files and CRF data. Developed and presented CRA training session to CRO vendor of monitoring staff located in the U.K. Reviewed, processed and reconciled Serious Adverse Events (SAEs).Reviewed data listings, generated queries, coordinated and tracked query resolution on 24 months of data from 2,400 subjects in preparation for database lock and rolling unblind of patient data. Mentored and trained new Clinical Operations personnel.

Oversaw data collection and patient care per pharmaceutical research protocols in accordance with Institutional Review Board, FDA and GCP guidelines. Served as primary contact for patients, study physicians and sponsor companies to ensure quality research and ethical standards were achieved. Performed informed consent procedures, medical history reviews and study specific intake interviews and assessments. Maintained regulatory binders, source document files, drug storage and accountability records. Transcribed source document data onto paper CRFs, via RDC (electronic data capture) and performed CRF data fax submissions.Reconciled data clarification forms.Met with CRAs regularly to discuss study data, patient recruitment and protocol criteria.Attended Investigator meetings and participated in internal and sponsor audits.