Partner with US, EU, and APAC Operations leaders to build go-to-market strategies in the US and EU. Collaborate with global partners to develop capabilities that are uniquely fitted to each clients needs.

Collaborate with BPX key stakeholders to influence product builds, marketing strategy and materials, generate leads for industry leading product solutions, build proposals and budgets for various client needs, outline contract requirements, and oversee solution implementation.

Provide technology enabled and cost-effective clinical development research services for phase I-IV clinical trials and regulatory support for biotechnology, pharmaceutical and medical device companies.Please contact me directly for more information at 615.513.2854 or Alex.Baldridge@Caidya.com

Provide technology enabled and cost-effective clinical development research services for phase I-IV clinical trials and regulatory support for biotechnology, pharmaceutical and medical device companies.Please contact me directly for more information at 615.513.2854 or abaldridge@clinipace.com

The Clinical Trial Manager II is responsible for the day to day leadership and management of monitoring services for clinical projects, including direct communication and interaction with investigative sites, Clinical Research Associates (CRAs), and the project Sponsor. This position ensures the on time and high quality delivery of: project specific on-site and remote monitoring services; accountability for clinical monitoring team training compliance; tracking of critical project tasks; strategic and tactical study enrollment support including, project-specific enrollment planning; and project accountability for CRA utilization.

Lead a team of 12 CRAs based at regional locations throughout the US and Canada. Provide line management support & strategy as well as operational direction. Ensure direct reports are meeting project timelines, milestones, & deliverables and are in compliance with SC SOPs & federal regulations. Lead & collaborate in departmental initiatives to develop new processes, SOPs, improve colleague retention, & encourage engagement. Created new-hire onboarding tool for CRAs, CRA Managers as well as a tools for reporting of the expenses. Participate in development, improving & training for the CRA Training program.• Aid in improving & maintaining clinical operations • Manage clinical monitoring resource needs & establish contingency plans for key resources• Establish, monitor, & track performance metrics & productivity standards • Oversee new hire onboarding process to ensure team has completed the appropriate training• Build & maintain strong sponsor and organizational team relationships for the success of clinical trial management• Implement to completion with a key focus on managing project timelines for clinical deliverables & oversight of investigative sites• Work with Project Managers to develop, maintain, & implement applicable study plans, train staff, & ensure adherence to plans• Initiate improvements to enhance the efficiency & the quality of the work performed on assigned projects• Conduct co-monitoring visits with CRAs to document training, assess individual performance & adherence to Sarah Cannon & ensure quality assurance/control of CRA visits• Review, manage & approve travel schedules, project workload, expense reports, time off requests & timesheets for CRAs and other staff, as designated• Assist in the interview and hiring process for CRAs & other colleagues• Conduct all monitoring visit types as needed to fulfill study & sponsor needs

• Assist in the Investigator selection and qualification process• Assist in the development of patient recruitment strategy• Attendance at Investigator Meetings• Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company standard operating procedures, applicable regulatory requirements and defined quality and performance standards• Ensure site IRB approval is current and all IRB documentation is in order• Maintain site monitoring schedule and serve as the principal point of contact for investigational sites• Document and report on clinical study progress (i.e. patient recruitment and discuss potential opportunities and risks with respective Project Team members)• Ensure patient safety is maintained and informed consent procedures are carried out• Provide training and update investigative site team of any changes in study conduct and documentation requirements• Ensure continued acceptability of the investigator, clinical site team and facility• Review clinical data, source documentation, CRF, and investigative site regulatory files• Work closely with data management and site to resolve discrepancies• Ensure investigational product accountability accuracy and oversee investigational product inventory• Liaise with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies• Meet with clinical study sponsor representatives as requested• Submission of routine monitoring visit reports and follow-up letters as per required timelines.• Ensure resolution of issues with investigative sites• Work closely and effectively with all other department personnel to ensure appropriate communication and study conduct • Maintain awareness of current developments in therapeutic area relative to assigned projects

• Assist in the Investigator selection and qualification process• Assist in the development of patient recruitment strategy• Attendance at Investigator Meetings• Perform and document pre-study site evaluations, site initiations, regulatory document collection, interim monitoring and study close out visits in accordance with GCP, study-specific requirements, clinical monitoring plans, company standard operating procedures, applicable regulatory requirements and defined quality and performance standards• Ensure site IRB approval is current and all IRB documentation is in order• Maintain site monitoring schedule and serve as the principal point of contact for investigational sites• Document and report on clinical study progress (i.e. patient recruitment and discuss potential opportunities and risks with respective Project Team members)• Ensure patient safety is maintained and informed consent procedures are carried out• Provide training and update investigative site team of any changes in study conduct and documentation requirements• Ensure continued acceptability of the investigator, clinical site team and facility• Review clinical data, source documentation, CRF, and investigative site regulatory files• Work closely with data management and site to resolve discrepancies• Ensure investigational product accountability accuracy and oversee investigational product inventory• Liaise with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies• Meet with clinical study sponsor representatives as requested• Submission of routine monitoring visit reports and follow-up letters as per required timelines.• Ensure resolution of issues with investigative sites• Work closely and effectively with all other department personnel to ensure appropriate communication and study conduct • Maintain awareness of current developments in therapeutic area relative to assigned projects

Identify, select, initiate and close-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with SOPs/WPs, applicable regulations and principles of ICH-GCP.Recognize, exemplify and adhere to values which center around a commitment to People, Clients and performance.To contribute to a culture of process improvement with a focus on streamlining processes adding value to business and meeting client needs.Maintain timelines. Ensure accuracy and completeness of data entered into various systems.Familiarity with principles of investigator recruitment.Assist with coordinating all the necessary activities required to set up and monitor a study, including the following:- Identify investigators- Help, when requested, in preparation of regulatory submissions- Design subject information sheets and consent forms- Coordinate documents translation, verification and back translations where required- Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements- Pre-study/placement and initiation visits- Conduct regular monitoring visits in accordance with site monitoring SOP/Sponsor site monitoring SOP as appropriate- Maintain all files and documentation pertaining to studies- Motivate investigators in order to achieve recruitment targets- Complete accurate study status reports- Ensure the correct storage of drugs and diligent account of all drugs in accordance with SOPs- Keep the Project Manager regularly informed- Process case record forms to the required quality standards and timelines- Deal with sponsor generated queries in a timely manner- Ensure the satisfactory close-out of investigator sites- Co-operate with sponsor QA personnel in the conduct of QA audits- Participate in feasibility studies for new proposals

Identify, select, initiate and close-out appropriate investigational sites for clinical studies. To monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with SOPs/WPs, applicable regulations and principles of ICH-GCP.Recognize, exemplify and adhere to values which center around a commitment to People, Clients and performance.To contribute to a culture of process improvement with a focus on streamlining processes adding value to business and meeting client needs.Maintain timelines. Ensure accuracy and completeness of data entered into various systems.Familiarity with principles of investigator recruitment.Assist with coordinating all the necessary activities required to set up and monitor a study, including the following: - Identify investigators - Help, when requested, in preparation of regulatory submissions - Design subject information sheets and consent forms - Coordinate documents translation, verification and back translations where required - Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements - Pre-study/placement and initiation visits - Conduct regular monitoring visits in accordance with site monitoring SOP/Sponsor site monitoring SOP as appropriate - Maintain all files and documentation pertaining to studies - Motivate investigators in order to achieve recruitment targets - Complete accurate study status reports - Ensure the correct storage of drugs and diligent account of all drugs in accordance with SOPs - Keep the Project Manager regularly informed - Process case record forms to the required quality standards and timelines - Deal with sponsor generated queries in a timely manner - Ensure the satisfactory close-out of investigator sites - Co-operate with sponsor QA personnel in the conduct of QA audits - Participate in feasibility studies for new proposals

Responsible for the independent preparation, review and approval of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws and other guidelines and ethical standards – within specific timelines and quality standards; responsible for independent preparation, review and approval of site level critical documents for Investigational Product (IP) release in accordance with regulatory / sponsor requirements – within specific timelines and quality standards; work with sites to finalize Site Specific Informed Consent Forms in accordance with ICON, site and sponsor specifications. Accountable for the collation and verification of the submission documentation in assigned countries; accountable for the dispatch and tracking of submissions to CA, ECs and other bodies as appropriate in assigned countries. Review and negotiate Investigator contracts and budgets. Use sponsor approved fallback language and budget parameters appropriately. Maintain communication with Investigative sites, Sponsors and internal personnel regarding status of contract and contract-related documents

Increased weekly enrollment from 30% to 85% or higher every week for CDC EPIC study. Handled multiple contacts and brought a team together while completing weekly, monthly and quarterly study goals. Performed chart audits, all study related documentation, and patient consenting under Good Clinical Practices. Operated under four studies: EPIC (lead coordinator), SPRINT, MTG Fresh Tissue, and CDC Flu Study.

Helped develop study protocol for Statin Trial for Influenza Patients. Maintained and managed communication with all clinical sites. Reviewed and managed all documentation from clinical sites

Live cell culture care. Performed RT-PCR, gene expression and gene cloning of carcinogenic cell lines. Awarded first place for research at Tennessee academy of Sciences in October of 2010.