Ryan Putman Email & Phone Number

Plymouth, Mi, Us

Plymouth, Mi, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

-Responsible and accountable for the management of the Clinical Operations team with particular emphasis on teamwork, quality, timelines, budget, metrics and compliance with the project plans and SOPs-Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: pre-study visits, site initiation visits, routine monitoring visit, motivational visits, close-out visits, audit support visits-Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines-Ensure that all study related, clinical related documents are tracked, filed and reviewed (QC check) and complete according to the SOPs, regulatory requirements and protocol-Responsible and accountable for understanding and managing the clinical operations budget for the project and ensure that the activities are within budget and scope of work and to discuss with the project team to support financial progress and team utilization-Communicate effectively with all members of the project team and client as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with Quality and the project team on Corrective and Preventative Actions-Perform other duties as required by the department or project team

Durham, North Carolina, Us

-Conduct feasibility activities across therapeutic areas with outreach to investigators to optimize projections of country enrollment and timelines-Provide credible country assessments to study teams via strategic assessment of the protocol-Identify risks and contingencies to successful study execution and recruitment planning through collaboration with investigators, thought leaders, medical affairs, and site management colleagues-Support patient recruitment strategic plan for each trial in collaboration with local study team and other stakeholders. Measure success for different strategies and refine strategies, tools or process to enhance effectiveness. -Establish partnerships and explore creative patient recruitment strategies depending on therapy area and indication which could include use of social media or exploring partnering with organizations for developing and utilizing patient registries and databases -Provide single point of contact to preferred Oncology sites to enhance site expertise and drive efficiencies across trials -Promote clinical trials to patient advisory group by providing balanced and objective information on clinical trials; translating their rationale and competitive trial difference to patient advisory groups and HCP -Proactively research and understand the local landscape for new product/indication pipeline (the background on disease state, understand Bayer study drug, other competitive study drugs, patient population, standard of care and medical practices as it relates to patient recruitment).

Princeton, New Jersey, Us

Provide support to the clinical operations team for multiple clinical trials in oncology.-Responsible and accountable for the management of the Clinical Operations team with particular emphasis on teamwork, quality, timelines, budget, metrics and compliance with the project plans and SOPs-Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: pre-study visits, site initiation visits, routine monitoring visit, motivational visits, close-out visits, audit support visits-Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines-Ensure that all study related, clinical related documents are tracked, filed and reviewed (QC check) and complete according to the SOPs, regulatory requirements and protocol-Responsible and accountable for understanding and managing the clinical operations budget for the project and ensure that the activities are within budget and scope of work and to discuss with the project team to support financial progress and team utilization-Communicate effectively with all members of the project team and client as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with Quality and the project team on Corrective and Preventative Actions-Perform other duties as required by the department or project team

Princeton, New Jersey, Us

Provide global project management support for multiple early phase clinical trials in oncology-Serve as client primary contact for areas as assigned-Develop and maintain relationships with clients to meet/exceed client satisfaction expectations-Perform trip report review, quality issue escalation, and issue/risk resolution for regional sites-Manage multiple third party vendors-Provide support to investigative sites regarding enrollment and protocol specific questions-Regularly review the time analysis query (TAQ) to ensure study billing is in line with the executed contract and billing guide-Track client project metrics and participate in internal project review meetings-Assist in the successful design, implementation, tracking, and revision of projects plans

Raleigh, North Carolina, Us

Provided support to the managers and our client while processing clinical trial safety reports for a global pharmaceutical company.-Handled SAE reconciliation between the safety and clinical databases for 14 studies-Tracked, and performed, case deletions from the Argus safety database-Managed the Argus worklow and assigned cases, as needed, to ensure on time case locking and regulatory reporting-Assisted the project leads in resolution of case related questions -Worked with submissions to identify and correct E2b errors resulting in failed submissions

Raleigh, North Carolina, Us

Managed multiple pharmacovigilance projects and provided daily oversight of SAE processing and ARISg workflow-SMP creation and annual updates-Maintaining and uploading of project documents on shared drives-Provide project/product training-Liaison with sites and CRAs for query resolution-Quality assurance of cases-Project case triage and assigning of cases on the GSPV tracker-Distributing and notifying the project team on project updates and training as required-Monthly/weekly tracking of custom reports to project team

Raleigh, North Carolina, Us

Provided higher level support to the managers and our client while processing both solicited and unsolicited safety reports.-Acted as an overall quality document subject matter expert-Managed the Argus worklow and assigned cases, as needed, to ensure on time case locking and regulatory reporting-Assisted the project leads in resolution of case related questions -Acted as the data entry workflow step subject matter expert in Argus 7-Ran performance qualification script testing for an Argus 4.2 to Argus 7 upgrade-Trained over 200 existing new and existing staff, in 3 regions, on Argus 7 function and Argus 7 workflow-Revised quality documents and training materials to ensure accuracy, completeness, and consistency

Ann Arbor, Mi, Us

In addition to the data management responsibilities associated with the clinical subjects coordinator position, I handled high level study coordination for 10 studies.-Created and revised case report forms for investigator initiated studies-Developed team work aids to help educate new employees and standardize processes-Presented potential industry sponsored studies at internal feasibility meetings-Mentored junior staff on role responsibilities and team processes-Created Velos calendars for tracking of patient milestones and study billing-Prepared DSMB reports

Ann Arbor, Mi, Us

Core responsibilities in data management, handling patient data from screening through study completion. I enrolled patients on over 25 studies for both investigator initiated and industry sponsored studies in over 8 diseases within the leukemia and lymphoma team.-Built and maintained patient source binders-Conducted audits for the Investigational Drug Service-Prepared protocol deviation and SAE reports-Performed data abstraction from patient medical records-Entered data onto paper CRFs and multiple electronic data capture systems (Oracle, InForm, eClinical, RedCap, Velos)

Graduate Certificate, Clinical Research Administration

Bachelor Of Science (Bs), Kinesiology