Kathleen Johnson

Constructive analytical person while deadline focused with time demands, incomplete information and/or unexpected events

• Good organizational ability, communication, and people skills
• Ability to work in a team environment and collaborate with peers
• Ability to mentor junior members of the department and train sites all over the world
• Ability to develop and maintain client relationships
• Ensure all work performed in strict accordance with protocols, global harmonized SOPs, and Good Clinical Practices
• Proficient in multiple database platforms and medical data records
• Accountable for learning innovative technologies and applied processes and keeping up to date with industry wide technology for process improvement
• Contribute to the development and implementation of departmental policies, standard and process improvement initiatives. Compassionate and respectful; love working with children and young people and teaching them to be resourceful.

part time substitute teacher and math paraprofessional - Mohegan Elementary School, Montville Schools - Montville, CT

(2024-06)

Consultant; Lead Portfolio Manager, Lead Clinical Data Manager, Sr. Clinical Trial Manager, Lead External Data Specialist - Fortrea (was LabCorp, Covance, Chiltern, Ockham)

(2014 - 2024-02)

retired

• Integral member of the Clinical Data Management Team, participating in clinical trial creation and data management activities in support of clinical studies and organizing and implementing database closure activities;
• Perform all data management activities through study life cycle of study;
• Collaborate with and supervise vendors (labs) in setting up, managing, and completing trial database systems through database lock;
• Perform database design and conduct database validation and test activities;
• Perform clinical data review;
• Organize and ensure accuracy of all coding and Serious Adverse Events monitoring and reconciliation activities;
• Develop, review, and maintain all study documentation.
• Work with programmers and statisticians to create reports for reviewing data.
• Provide necessary clinical data reports for internal and external meetings.

Owner/Operator - Palmer’s Cove Marina, Inc. - Noank, CT

(1980 - 1994)

• Bookkeeping/Accounting; Office duties
• Sales: Boats, motors, trailers, marine accessories and part, tools, gas, bait and labor
• Ordering and stocking
• Cleaning: boats, showroom, offices shipping domestically in US and receiving of home goods from India, China, and other countries (warehouse); part-time position - I cannot remember name of business

(1994 - 1995)

Teacher’s Assistant, Special Needs teens - Devereux Foundation - Red Hook, NY

(1994 - 1996)

Customer Service Representative - MPN Insurance - Kingston, NY

(1996 - 1997)

Salesperson - Whyevernot - Mystic, CT

(1997 - 1997)

• Retail sales, display set up, ordering, stocking (clothes, home goods, jewelry, cards)
• Cleaning store and setting up merchandise and displays

Pharmacist Technician, Pharmacy - Pfizer - Groton, CT

(1997 - 1999)

Project Assistant, Archivist, Regulatory Affairs Associate - Pfizer - Groton, CT

(1999 - 2003)

Clinical Data Manager - Client Associated Businesses - Niantic, CT

(2003 - 2014)

Ward Clerk in an Emergency Room and a Nurses’ Assistant in nursing home - NY for several years switchboard operator and receptionist - nursing care facility

Bachelor’s Degree - Eastern Connecticut State University