Manager Management

Kim B. Wells, M.Ed.

EDUCATION

M.S., Education

Cabrini College, Radnor, PA

B.S., Science (Cum Laude)

Rosemont College, Rosemont, PA

Immaculata University, Immaculata, PA

Doctorate in Higher Education (Anticipated graduation date May 2019)

RELEVANT SKILLS

Highly skilled professional with over 17 years of experience working in the Pharmaceutical/ Medical Device/Laboratory Industry

Excellent communication skills, excels in both verbal and written articulation

Client Services Experience/Building Strategic Client Relationships

Proficient on various contract types (SOW, GLSA, WO, Change Order, NDA, MSA, Amendments, Project Statement, CTA and EULA)

Collaborate with Human Resources, Finance, IT, Contract Operations, Legal, and other Commercial Business

Good understanding of Clinical Study Management including monitoring, and data management

Proficient in various software applications: JD Edwards, Savion, EFS Legal Databases, Global Electronic Library (GEL), CMS Open Payments Portal, External Expert Database, SAS Viewer, SAS JMP, Hyperion, MS Office, Visio, CRM, Microsoft Windows XP, MS Project management tools and application, Boomerang, Ex check, Oracle, Lotus Notes, SharePoint, ARIBA, Global Per Patient Cost Database, SAP, Grant Plan, Grants Manager (GM), Contract & Rebate System (CARS), Clinical Trial Management System (CTMS), IMPACT, Captivate, Adobe Presenter, Totality, Enovia, Trackwise, Concur, DAX, Salesforce, CRM, Learning Management System (LMS), Interactive Response Technology (IRT), Electronic Clinical Outcome Assessment (Ecoa) and Prism

CORE QUALIFICATIONS

Proficient knowledge and understanding of relevant regulations, laws, Medical Terminology and industry guidelines (e.g. the Federal Food, Drug, and Cosmetic Act, European Medical Devices Directives, Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, UK Anti-bribery Act, OIG guidance, Food and Drug Administration guideline, PhRMA Code, AdvaMed Code and Eucomed Code)

Develop, implement and manage compliance monitoring program

Provide regular reports detailing audit results, regulatory violations, the status of investigations, corrective or preventive actions underway and any recommendations for compliance program improvements

Manage multiple complex contract negotiations

Assist in aggregating, processing, and distributing coding and HIPAA data

Develop action plans to manage compliance risks

Develops, initiates, maintains and revises policies and procedures for the general operation of the Compliance Program and its related activities to prevent unethical or improper conduct

Experienced in assessing company culture, defining both short and long-term goals and objectives as well as implementing new initiatives

WORK HISTORY

Q2 Solutions – Collegeville, PA 2016 to Present

Global Project/Account Manager, Clinical Trials

Primary point of contact for Pharmaceutical Sponsors, Vendors, and CRO teams

Develop/maintain detailed timelines and resource projections for multiple clinical trials

Manage study through study start and study closure

Adhere to companywide Standard Operating Procedures (SOP’s)Monitor quality of the clinical trial and proactively determine and implement solutions for any issues that arise

Comprehensive knowledge of central laboratory operations

Proficient in protocol review and SOP writing/review

Monitor budget throughout the length of the study

Revenue forecasting and invoice reconciliation

Interact/coordinate with other internal departments, including but not limited to; finance, contracts/legal, regulatory, and data management to achieve the program goals

Ensure timelines are met and provide quality results to client

Assist with training of new members of the project management team

Present at Investigator Meetings and provide training sessions

Establish strong working relationships with sponsor contacts

Manager overall client expectations for primary Vendors/CRO’s

Senior Contracts Analyst, Clinical Trials

Team Lead on contract development process for large, complex contracts

Streamline the process from proposal development through contract signature

Work closely with project teams to determine appropriate terms and conditions of clinical contracts

Collaborate with cross-functional teams to support client needs, service improvements and troubleshoot operational issues that affect client satisfaction

Develop and Revise the contracts and related budgets and scope of work. Ensure the scope of work is defined correctly and budgets reflect the scope

Negotiating and executing clinical agreements and investigator budgets

Assist in the negotiation of legal contracting text using Quintiles Global Contracting Policy, templates fallbacks

Therakos - West Chester, PA 2014 to 2016

Global Healthcare Compliance/Regulatory Specialist

(Cross Functional)

Ensures effective execution of Health Care Compliance (HCC) related initiatives: Implementation of Sharepoint and HCC-LIFE along with a global cross functional team

Ensures implementation of transparency reporting for payments and transfers of volume made to healthcare professionals in accordance with government regulations (US Federal Sunshine Act & France Sunshine Act)

Perform HIPAA incident investigations under the direction of the Privacy Officer

Manages the development and execution of risk-based testing & monitoring plans, along with appropriate metrics to demonstrate the state of the HCC program

Assists in the development, implementation, and maintenance of appropriate compliance policies and procedures

Assist with establishing Key Performance Indicators (KPIs)

Develop, implement and manage compliance monitoring program

Develop action plans to manage compliance risks

Responsible for the efficient, timely and compliant management of clinical contracts, pricing submissions and supporting processes and systems

Support Therakos pricing policy by analyzing the clinical pricing, impact of proposed price increases, contract strategies, and other pricing decisions and impacts on the net selling price of the instruments

Perform HIPAA assessments and audits

Develop, track and ensure adherence to corrective action plans

Collaborate with Finance, IT, Contract Operations, Legal, and other Commercial Business functions to assure the interdependencies of commercial and Federal pricing

Support to EU Regulatory agencies

Distributor training – partnering with HCC Officer to deliver both Regulatory Affairs and HCC Training to 3rd part intermediaries

Due Diligence review and certification for 3rd party contractors

Management of 3rd party Regulatory CRO

Assist with the preparation of Regulatory documentation for submission

Drexel University - Philadelphia, PA

Graduate Fellow 2013

Initiated and executed training sessions for student organizations

Collaborated with the assistant director on strategic initiatives to improve the student experience

Chaired the LGBTQ committee leading activities in support of the grand opening for the newly dedicated center supporting minority student interns

Montgomery County Community College - Pottstown, PA 2012

Director, Minority Female Mentoring Program

Designed and developed a strategic recruitment plan to bring minority students to Montgomery County Community College in Pottstown, PA

Analyzed enrollment reports to retain students

Scheduled, administered, and proctored placement testing, testing for distance learners, classroom make up testing, testing for students with disabilities, and certification testing

Administered and monitored placement testing at local High Schools in Montgomery County

Merck-North Wales, PA 2011 to 2012

Global Agreement Specialist – Vendor Strategy & Management Group

Authored, negotiated, and executed global consultant contracts in accordance with Global Development Plan

Reviewed and approved contract language changes in accordance with Merck policy and country laws and guidelines. Provided guidance to Contract Research Organizations (CROs) contracted to negotiate Clinical Trial Agreements (CTAs) globally. Collaborated with the global Contracts and Grants team to review and analyze contractual terms and conditions in order to reach acceptable language

Adhered to SOPs, statement of work (SOW) and budget meet the needs of both the clinical trial and all legal requirements. Responsible for managing and facilitating any change orders to the SOW ethical standards, and departmental compliance as determined by sponsor management as well as corporate, HCC and QA guidelines

Responsible for drafting, negotiating, and finalizing Clinical Trial Agreements (CTAs) with sites as they relate to various clinical projects

Drafted investigator grants according to sponsor's grant pricing guidelines, clinical trial protocol, and other clinical trial information

Utilized grant development databases (e.g., PICUS) as required. Establish Master Service Agreements and standardized budget templates with frequently used sites

GlaxoSmithKline - King of Prussia, PA (Various Departments) 1999 to 2010

Healthcare Professional Compliance Analyst 2006 to 2010

Lead a team of four R & D Analyst responsible for facilitating the contracting process with the sponsor, legal, and HCP/External Experts

Define project objectives, requirements, and assumptions necessary to structure a project or activity

Part of the pilot committee involved in rebates with drug stores (CVS)

Plan, schedule, and control project activities to fulfill objectives and satisfy project requirements

Represented R&D by discussing and managing clinical payments and budgets directly with investigators to ensure company policies and contractual terms are understood and applied

Managed financial relationships with third parties (CRO, ARO, and SMO) to collect and analyze HCP related data. Reviewed contract request to ensure interactions with HCP were appropriate and adhered to Clinical and Regulatory requirements

Monitored and analyzed financial HCP data to ensure compliance with Clinical and Regulatory financial disclosure requirements

Lead compliance initiatives pertaining to aggregate spend transparency and interactions with Healthcare Professional and organizations. Managed preparation and submissions of aggregate spend disclosure reports required by various states and the federal government

Lead business and technical projects associated with companies aggregate spend reporting program. Monitored tracking and reporting of HCP Spend (Sunshine Act). Aggregate spend covers (1) finding & categorizing spend, (2) harmonizing data to enable efficiency in reporting, and (3) reporting & leveraging

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