•Implement and maintain Veeva Vault eTMF and Veeva CTMS systems within the organization•Inventory and maintain a listing of any TMFs held by previous vendors, their filing location, status, physical storage and compliance requirements•Inventory and maintain a listing of any company Policies and SOPs, their filing location, status, physical storage and compliance requirements•Develop and maintain robust TMF document submission and QC Company Policies, SOPs and Guidelines that support global audit readiness metrics and objectives•Serves as a point of contact for business development activities as it relates to the TMF and serve as Veeva CTMS Business Administrator and key point of contact with the vendor•As Veeva Vault eTMF and Veeva CTMS Business/Vault Owner, participate in system configuration and validation review/activities for each system as needed•Help establish workload, forecasting on demand, and drive resource planning connected to the budget to ensure adequate delivery of TMF services and systems trainings

• Coordinate appropriately with all workstreams (Clinical Operations, QA/Compliance, IT and the external parties/vendors) during the eTMF solution selection phase and implementation phase of the selected system.• Coordinate with the respective stakeholders in drafting and obtaining sign-off for the detailed Business User requirements document.• Review, update as appropriate the ‘Request for Proposal (RFP)’ document and obtain stakeholder alignment on the final RFP to be sent to the short-listed eTMF solution vendors/solution providers.• Primary point of contact for collecting all the RFP responses and fill in thebaseline vendor scorecard. Ensure scorecard is effectively designed to evaluate vendors and solution delivery options. Coordinate with the internal stakeholders in completing the final vendor scorecard.• Lead role in coordination with the internal stakeholders andimplementation partner/service, in defining and finalizing the appropriate businessprocess flows. This includes not only future studies to be on-boarded to the selectedsystem but also completed studies that need to be archived.• Conduct steering committee and project core team meetings with the project teammembers, steering committee members, project vendors and other identified internal Cytokinetics team members.• Project leadership role in holding the implementation partner/solution provider accountable to deliver to the agreed-to financials/budget.• Establish a playbook that outlines how the Cytokinetics stakeholders and externalparties (Solution provider/services provider) will interact with the system and with each other once the system is implemented.• In coordination with the Cytokinetics internal stakeholders, develop appropriate SOPs and Work Instructions, then coordinate with QA to ensure these are articulated effectively.• Create the overall validation plan, deliverable, and ensure that all validation related documents are created and finalized.

•Implement and maintain Veeva Vault eTMF and Veeva Quality Docs system within the organization•Inventory and maintain a listing of any TMFs held by previous vendors, their filing location, status, physical storage and compliance requirements•Inventory and maintain a listing of any company Policies and SOPs, their filing location, status, physical storage and compliance requirements•Develop and maintain robust TMF document submission and QC Company Policies, SOPs and Guidelines that support global audit readiness metrics and objectives•Serves as a point of contact for business development activities as it relates to the TMF and serve as Veeva Quality Docs Business Administrator and key point of contact with the vendor•As Veeva Vault eTMF Business Administrator and Veeva Quality Docs Vault Owner, participate in system configuration and validation review/activities for each system as needed•Help establish workload, forecasting on demand, and drive resource planning connected to the budget to ensure adequate delivery of TMF services and company trainings

•Implemented and maintained Veeva Vault eTMF system within the organization•Inventoried and maintained a listing of any TMFs held by previous vendors, their filing location, status, physical storage and compliance requirements•Developed and maintained robust TMF document submission and QC SOPs and Guidelines that support global eTMF audit readiness metrics and objectives•Served as a point of contact for business development activities as it relates to the TMF and serve as eTMF System Administrator and key point of contact with eTMF vendor•Prepped teams for document migration, which includes document inventory, data clean up, and FTP activities• Gathered company requirements for system configuration, system validation and future enhancements • Customer/Vendor management of UAT, Training, and communications.•Helped established workload, forecasting on demand, and drive resource planning connected to the budget to ensure adequate delivery of TMF services•Participated in audits and inspections and ensure that Endo is audit and inspection ready at all times.•Directed the ongoing quality control reviews of project level TMFs, utilizing best practices•Provided document management guidance to cross-functional teams preparing for health authority submissions for marketing approval; coordinate efforts for legacy studies and provide hands-on support for clinical operations•eTMF system administrator for day-to-day operations; main contact for therapeutic area management, global directory object management, global access assignment, and study object management in eTMF•Established key performance indicators, productivity measures, and performance metrics for executive level review•Developed and delivered training on TMF processes to relevant stakeholders•Oversee day-to-day activities of TMF Associate(s); plan, assign and direct work; escalate issues with potential solutions•Participated in the identification, interviewing, evaluation, and on-boarding of resources

•Defines and manages processes associated with the storing, archiving, indexing, scanning, and classifying of study documents and related records regardless of location, format or media type•Prepares and maintains TMF related manuals, training materials, policies and procedures and other related quality documents,•Reviews and provides comment on SOPs and other Controlled Documents that impact the TMF•Assists clinical teams in the development of eTMF plans and other eTMF related activities•Participates in the selection, management, and oversight of clinical vendors hired to perform TMF management activities, if applicable,•Assist and manage eTMF Vendor, UAT training and eTMF sytem implemtation and updates.•Trains internal and external vendor staff regarding TMF processes, work flows, metadata, naming conventions, QC checks, etc.•Download documents from a centralized repository, review the documents for completeness and then will categorize them in accordance to the DIA Reference Module.•Responds to internal and/or external information inquiries related to the TMF; supports internal and external audits and inspections, including development and implementation of CAPA activities and results•Ensure that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.•Continuously evaluates regulatory requirements for TMF management (active and archival) and assesses impact to company’s established processes; contributes to risk evaluation and mitigation strategies•In collaboration with IT, manages the TMF technology provider(s)•Responsible for the complete and accurate Clinical Study Trial Master Files (TMF) through review of study documentation, ensuring quality, consistency and timely filing across all clinical trials. •Responsible for regulatory document collection, QC and approval (familiar with 1572s, IRB documents, trial master files content)

•Defines and manages processes associated with the storing, archiving, indexing, scanning, and classifying of study documents and related records regardless of location, format or media type•Prepares and maintains TMF related manuals, training materials, policies and procedures and other related quality documents,•Reviews and provides comment on SOPs and other Controlled Documents that impact the TMF•Assists clinical teams in the development of eTMF plans and other eTMF related activities•Participates in the selection, management, and oversight of clinical vendors hired to perform TMF management activities, if applicable,•Assist and manage eTMF Vendor, UAT training and eTMF sytem implemtation and updates.•Trains internal and external vendor staff regarding TMF processes, work flows, metadata, naming conventions, QC checks, etc.•Download documents from a centralized repository, review the documents for completeness and then will categorize them in accordance to the DIA Reference Module.•Responds to internal and/or external information inquiries related to the TMF; supports internal and external audits and inspections, including development and implementation of CAPA activities and results•Ensure that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.•Continuously evaluates regulatory requirements for TMF management (active and archival) and assesses impact to company’s established processes; contributes to risk evaluation and mitigation strategies•In collaboration with IT, manages the TMF technology provider(s)•Responsible for the complete and accurate Clinical Study Trial Master Files (TMF) through review of study documentation, ensuring quality, consistency and timely filing across all clinical trials. •Responsible for regulatory document collection, QC and approval (familiar with 1572s, IRB documents, trial master files content)

Responsible for performing investigative site recruitment/feasibility, site project training, remote clinical data monitoring and resolution, site progress status tracking, in-house site management, documentation filing, and other duties in accordance with Sponsor and/or UBC requirements. Performs essential document collection and review for site start up and initiation in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and good documentation practices. Create and review project planning documents including but not limited to Essential Document Review Plan (EDRP), Site Management Plan, and Project Plan. Track milestones, generate study metrics, and provide written and verbal updates to internal and external customers. Demonstrates ability to successfully lead and mentor CTS staff, take on high level tasks as delegated by Project Manager/Functional Manager, escalate and mitigate risk as appropriate, and demonstrates complete understanding of UBC systems and work environment.

• Work closely with Sponsor and Project Manager to ensure regulatory compliance for assigned project(s)• Draft Essential Document Review Plans to outline the completion, collection, review and submission of regulatory documents for assigned projects(s). Conduct ongoing regulatory review of regulatory documents collected by Clinical Site Support Specialists to ensure compliance with FDA regulations, International Conference on Harmonization/Good Clinical Practice Guidelines, standard operating procedures, and sponsor specific requirements• Final Reviewer of required approved regulatory documents prior to release of study drug or for initial submission to an Institutional Review Board/Ethics Committee• Ensure that sites are interacting with IRBs according to federal regulations and IRB requirements;• Maintain Site Master Files throughout study• Update and maintain critical study metrics; Track, Maintain, and QC Monitoring Visit Reports • Ensure that site timelines are met with regard to site activation and closeout • Assist PM and sites with advertisement and informed consent form creation/ approval process• Assist Project Manager with other projects upon request• Attend study team meetings/teleconferences • Attend investigator meetings and provide support, as needed• Assist Project Manager in maintaining project files and site correspondence• Assist UBC management with other projects upon request• Make recommendations to the Project Manager to increase efficiencies or quality in regulatory processes;• Liaise directly with Sponsor contact regarding regulatory documents and eTMF UAT and implementation

•Assists in maintaining, updating and disseminating progress reports, tracking tools, program timelines and project plans with project specific information collected from the functional lines of the global clinical trials in the program•providing administrative program assistance ensuring all project deliverables are met according to program timelines, budget, operational procedures and quality standards. •Assists in planning, coordinating, and tracking program activities and facilitates team communication under the supervision of the Sr. Director of Global Project Management ensuring compliance with SOPs, policies, working guidelines, good clinical practices, and applicable regulatory requirements •Ensures that the Trial Master File is accurate, complete and audit ready • To assist in quality control audits of clinical study documentation•Assists with the coordination and tracking of project-related information, status reports and communication across the project teams and departments •Provides administrative support for efficient project team meetings, both internal and external, including scheduling, participation, preparation and distribution of meeting minutes, and maintenance of action item logs•Manages the administrative start-up and close out activities

Responsible for the design and set up of complete and accurate Trial Master Files documentation ensuring compliance, quality, consistency and timely filing across all clinical trials. Responsible to ensure that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements. Responsible that the e-Trial Master Files are submission/inspection ready. Develops and assists with the implementation of the e-Trial Master File specifications. Regulatory packet requirements, blinded vs. unblinded documentation and location. Ensure Trial Master File project specifications are in alignment with program strategy and study time line milestones. Provide and conduct eTMF system set-up and training to all study team members. Ensure that all team members are compliant with Training according to SOPs and TMF processes. Provide consistent setup and maintenance of TMF requirements and processes and programs. Ensure that documentation flow for TMF documents meet the required timelines and intervene with action plans and follow up as appropriate. Conduct internal audits and assist with external audits related to the TMF processes and activities. Development of corrective action plans related to TMF findings. Review data quality outputs and audit outputs to identify trends per study and across programs. Provide Lessons Learned information. Comply with metrics established for performance TMF reviews Responsible to ensure that TMF documentation is completed prior to study close/submission. Attend all study team meetings as required. Assess clinical trial documentation being created internally and externally with for alignment with the Master Trial Master File Document List and applicable SOP’s. Assisting in with changes in scope and preparation of change orders . Clinical Trial Master List Documentation and SOP Review including voting and decision making.

Responsible for the preparation and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws, and other guidelines and ethical standards. Review and approve site level critical documents for Investigational Product release in accordance with regulatory/sponsor requirements. Attendance at Kick-Off, Investigator or study team meetings. Perform feasibility, site identification, site contract negotiation, and other study start up activities. Prepare, review, and submit submissions to ethics and regulatory and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct. Including ethics/regulatory/other relevant authority approvals for clinical trials, ethics/regulatory/other relevant authority approvals for trial amendments, ethics/regulatory/other relevant authority study notifications, authorizations for import/export of investigational products, clinical supplies, and biological samples, approvals from the national authorities for data protection. Develop and finalize Country Specific SIS/ICFs. Prepare and finalize Country Specific xml files. Review and translate Drug Labels. Perform independent quality review of submission packages. Collect and maintain current Regulatory/Competent Authority and Ethics Committee submission information, and similar information for other related organizations for assigned countries. Responsible for the translation and coordination of translations for documents required for submission. Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate CTMS. Responsible for the timely follow-up for queries made by CA/EC. Responsible for the collection of critical documents required for IP release. Assemble and distribute study materials to clinical and project teams, materials to study sites and investigator meetings and vendors.

Managed a team responsible for several aspects of workflow. Super-user within the eTMF team to be experienced and practiced in all elements of the eTMF workflow. Responsibility for authorizing and tracking leave, mid-year and annual performance development plans, training and personal development plans. Worked with colleagues on a proactive, effective and cost efficient approach to resource allocation to meet the needs of the business. Coordinated new staff induction plans & Phlexglobal training. Worked with Management team of eTMF Operations & Technical Development team to review processes and create changes to existing processes. Provided daily, weekly and/or monthly reports to Senior Team Leader. Analysis of project data and various matrices . Trouble shooting, resolving equipment problems/failures and rectifying processing issues immediately.Assisted in writing and review of relevant Phlexglobal Quality Processes and SOPs. Processed client documentation. Assisted in the design and implementation of all relevant systems. Conducted onsite Rater Certification Meetings, including program and conduct onsite knowledge checks via Audience Response Systems, and record onsite investigators’ meetings for archive purposes. Responsible for the following tasks supporting project service offerings: User Administration, Study Module creation, Online and Onsite meeting planning, moderation, conduct, report generation, and special projects, as determined by the Associate Director, Rater Training. Maintained the role of lead coordinator for: Data Monitoring Application – data entry and maintenance of patient visit sheet into the application, Rater/Site Specialist – Lead site/rater support specialist: primary point of contact for raters/site personnel regarding rater training. The lead site support specialist helps to manage metrics and rater status. Primary Monitor’s Contact – lead support specialist as primary point of contact regarding rater training.

Supported various day-to-day operational and administrative activities, including the planning and implementation of all project services. Assisted in the design and implementation of all relevant systems including, but not limited to, the Rater Training Workspace, Rater Selector Survey Report, Rater Training Report, Rater Certification Report, Applied Skills tracking, etc. Supported rater and site follow-up for all project services. Conducted onsite Rater Certification Meetings, including program and conduct onsite knowledge checks via Audience Response Systems, and record onsite investigators’ meetings for archive purposes. Responsible for the following tasks supporting project service offerings: User Administration, Study Module creation, Online meeting planning and moderation, Onsite meeting planning and conduct, report generation, Special projects, as determined by the Associate Director, Rater Training, Interacted with client, study team, and third-party personnel, Maintained the role of lead coordinator for: Data Monitoring Application – data entry and maintenance of patient visit sheet into the data monitoring, application, Rater/Site Specialist for a rater training project – Lead site/rater support specialist: primary point of contact for raters/site personnel regarding rater training. The lead site support specialist helps to manage metrics and rater status. Primary Monitor’s Contact – lead support specialist as primary point of contact regarding rater training. Assisted in the setup, conduct and follow-up of client meetings.

Set up and maintained regulatory study document files (Trial Master Files (Paper and Electronic) which may include Case Report Forms) using either RPS or client specifications. Ensured timeliness, orderliness and safekeeping of documents and files throughout their lifecycle within RPS. Entered and checked status of regulatory documents in clinical trial management systems. Interact with RPS Clinical Operations staff (e.g. Project Managers, Project Assistants, CRAs, and Quality Assurance), investigative site personnel, and clients in order to obtain proper clinical site documentation. Supported preparations and follow-up activities related to internal and client QA audits. Supported general Regulatory Document Room operations, e.g., provided documents (copies or originals) upon request, reviewed files that were received, tracked files that were borrowed, and shipped files to clients or third-party archives, according to applicable RPS SOPs. Maintained current awareness of all projects that were kept in the record room and their status. Assisted the Manager, Regulatory Affairs with the review of essential regulatory documents including FDA Form 1572, site-specific or study template informed consent forms, for completeness and accuracy. Provided assistance as needed to Manager, Regulatory Affairs

Assisted in Site Recruitment and Start-up processes by acting as a primary point of contact with investigative sites. Prepared, collected, tracked, filed and maintained Regulatory Documents throughout each study. Prepared site files for approval by Regulatory Management. Acted as a liaison between investigative sites and Clinical Research Associates in CRA absence. Management of CRA travel, tasks, and responsibilities throughout all studies. Ordered, tracked, and maintained study drug supplies and distribution. Generated and maintained study-specific tracking spreadsheets (e.g., patient enrollment, regulatory documents, site visits, vendor records, etc.). Managed Paper and EDMS Trial Master File’s for Phase I through IV trials. Trial Master File Reconciliation. Prepared, collected, maintained and completed IRB Submissions, Approvals and Informed Consents. Assisted in preparation, collection, maintaining Drug Safety/Pharmacovigilance submissions and distributions to Investigative sites. Managed and coordinated shipment of study supplies and documents to vendors, investigative sites, and IRB. Completed Audits of Investigator files in preparation for study closure. Participated in team meetings and provided status updates. Performed other tasks as requested by Clinical Project Managers.

Provided clerical and administrative support to project teams. Provided clerical and administrative back-up support to Administrative Assistant as needed. Set-up and maintained project files. Set-up and maintained investigator files. Faxed, photocopied, filed and distributed study-related documents. Managed Paper and EDMS Trial Master File’s for Phase I through IV trials. Trial Master File Reconciliation. Contacted study personnel at sites regarding administrative issues. Ordered office supplies as needed by project team. Generated and maintained study-specific tracking spreadsheets (e.g., patient enrollment, regulatory documents, site visits, and investigator payments). Regulatory Document Preparation of: 1572, Medical Licenses and CV’s, Financial Disclosures, Personal Data Consent Forms, Protocol Acceptance Forms, IRB Submission, Approvals and Informed Consents, Ship/mail supplies and documents to clients, investigator sites, and IRBs, Assist in assembling materials and binders for Investigators’ Meetings, Prepare regulatory binders (Study File Notebooks) for study sites, Created and Maintain Investigator contracts and payment documentation. Reserved various meeting halls and conference rooms and participate in team meetings.

• Duties include reviewing sick call sheets, running sick call clinic daily for inmates' care• Oversee Blood Lab and Infirmary (prn), phlebotomy, EKGs, PEs, vision screening, BPs, administer foot wraps/ soaks, cream ointments for psoriasis, poison ivy, eczema, fungal infections, etc., hot/cold packs, wart-offs, Albuterol treatments, ear irrigations, fingersticks (diabetes testing), administer oral medication under RNs supervision. • Medical records (MARS-Medical Administration Records) filing of all x-rays/lab/psych/TB results etc., faxing, order supplies, count, take and stock inventory as needed, and perform exit medical clearances for CCC and Parolees. Also travels to SCI- Gratersford Prison working as a Phlebotomist to run Blood Lab.