•Serve as primary point of contact providing guidance and oversight of data management activities in support of clinical research trials. •Provide expertise and support during study start-up, database development, in-stream production data cleaning, and database closure activities across client projects. •Ensure timeliness of deliverables while maintaining effective data processes within a specified budget. •Lead and facilitate meetings with external teams, providing and establishing project timelines, communicating study status updates and escalating any needs or concerns to cross-functional team members. Successfully coordinate with and update internal team members including statisticians, programmers, medical coders, and medical writers on project status or upcoming study milestones. •Collaborate with and advise clinicians, scientists, key opinion leaders, regulatory specialists, and study team members on data handling related to clinical studies. •Develop and communicate the data management plan for clinical trials and obtain understanding and endorsement from internal and client stakeholders. •Lead and provide guidance on database design and development in compliance with CDISC and C-DASH standards. •Ensure data collection parameters align with the SDTM and FDA submission guidelines. Perform internal validation and testing of data collection tools and ensure alignment with the clinical study protocol. •Review data for accuracy and validity as it is entered into the clinical database. Generate data queries and interact with study monitors and investigative sites for query resolution. Identify and work collaboratively and cross- functionally to implement process improvement measures at both departmental and project level.

•Generated and reviewed reports and report components for studies according to the protocol, format, data, and Good Laboratory Practices (GLPs) regulatory compliance requirements.•Review and evaluated laboratory data for adherence to protocols and regulatory requirements; requested corrections if discrepancies were found.•Responded to, clarified, and evaluated Quality Assurance Observations with the Quality Assurance staff, reviewed and completed Corrective and Preventative Action events; and addressed compliance issues.•Mailed reports to the Sponsor in accordance with established timelines.•Evaluated and prioritized study work (scheduled and unscheduled) to determine which reporting functions to complete. Was in constant communication about the prioritized schedules with the reporting team and assigned Study Directors.•Anticipated potential study issues and proactively worked towards resolutions; communicated

• Communicated with Study Directors and Sponsors, and interpreted complex study protocols and other Sponsor-provided information to ensure quality study conduct.• Represented department at study pre-initiation and pre-day one meetings.• Ensured proper review of assigned study-specific data for completeness prior to archival.• Participated in the completion of laboratory investigations and quality observations.• Supervisory responsibilities in accordance with the organization’s policies and applicable laws including interviewing, hiring and training employees; planning, assigning and directing work; appraising performance and completing annual performance review; rewarding and disciplining employees; addressing complaints and resolving departmental problems.• Prioritized and delegated workload amongst employees based on skill level and individual’s development plan.• Responsible for big picture scheduling of functions, delegating daily responsibilities of staff, set-up and monitoring the execution of study functions according to the protocol, study specific procedures (SSPs) and standard operating procedures (SOPs) using Task Scheduler (interdepartmental scheduling system) and Protocol Definition (interdepartmental study setup)• Reviewed study protocols for GLP and SOP compliance as well as provided feedback regarding potential changes.

• Performed in-process inspections of required technical functions to ensure adherence to the study protocol, Standard Operating Procedures (SOPs), and Good Laboratory Practices (GLPs)• Performed data audits to confirm compliance to the study protocol, SOPs and GLPs in comparison to the generated reports to ensure the accurate portrayal of the study data and events.• Accurately maintained master schedule and inspection audits for the entirety of assigned studies• Reviewed study protocols for GLP and SOP compliance as well as provide feedback regarding potential changes • Independently managed assigned personal study workload including reports, in-process inspection audits, master schedule and study pre-initiation meetings in conjunction with departmental schedule requirements.• Compared in-process inspection and study report data to that recorded in the corresponding area of the Laboratory Information Management System (LIMS) and Provantis.• Experience working with the following computer systems: Laboratory Information Management System (LIMS), Provantis (elcetronic data capture system) eDocs ( document management) QAAD (Quality Assurance Auditing system), Microsoft Office, Task Scheduler (interdepartmental scheduling system)• Continuous correspondence with study directors, sponsors and lab personnel in regards to study inspections

• Drew up, counted and administered radioactive dose to small and large animals• Performed pre and post-dose and total radiation counts using a dose calibrator• Performed wipe tests to check for radioactive contamination using a gamma counter• Communicated weekly with the Radiation Safety Officer in regards to wipe test results and findings• Decontaminated study rooms and equipment according to standard operating procedures• Induced and maintained anesthesia using injectable and inhalation anesthetics on small and large species for procedures and imaging modalities• Used non-invasive imaging modalities (SPECT, PET, CT) and biomarkers to help image particular targets or pathways• Collected blood on small animals (sublingual, tail vein and jugular)• Performed small animal necropsies and harvested tissues for post dose radiation counts• Prepared, review and archival of study books• Maintained laboratory organization, inventories, and equipment

• Assisted in the performance of preclinical in vivo drug and medical device development using surgical methods • Collected data according to standard operating procedures, protocols, and good laboratory practices• Worked with biological agents following BSL-2 guidelines• Prepared operating rooms, test subjects, instrument packs, and surgical records for preclinical studies• Induced and maintained anesthesia using injectable and inhalation anesthetics on small and large species for procedures• Administered tablet doses and numerous types of injections to small and large animals• Acclimated, trained and rewarded animals to prepare them for study related functions• Surgical setup and supervision of aseptic surgical study procedures• Collected data according to standard operating procedures, protocols, and good laboratory practices (GLP)

• Prepared solutions and cell cultures for biology labs• Gathered and assembled materials for various biology labs• Assisted in the set-up and tear-down of labs• Maintained cleanliness and organization of labs and laboratory equipment.

• Ran multiple educational programs for children• Exotic animal Handling• Provided excellent communication skills by giving educational presentations to large groups of people• Ran badge-in-a-day programs for boy and girl scouts to work towards earning a badge

• Supervised the kennel and its occupants• Prepared animals for surgeries, dentals, x-rays, examinations, and other procedures• Collected and analyzed blood, urine, and fecal samples• Assisted in training of new employees