Clinical Project Manager (Contract Position)• Studies include a Phase I prostate cancer diagnostic study and an international Phase II prostate cancer diagnostic study• Plan and implement assigned clinical studies to ensure compliance of study activities with applicable regulations, guidelines, principles of Good Clinical Practices and MIP Standard Operating Procedures• Work closely with the study coordinator to prepare and submit regulatory package to the Phase I site’s IRB, conduct SIV, and monitoring visits • Develop MS Project timelines to track study progress, manage vendors, and report to senior management • Contribute to the development of study documentation including, but not limited to protocols, eCRFs, ICFs, and CRF guidelines • Work closely with internal and external experts to develop technical manuals for imaging and surgical and pathology processes for the studies• Manage CROs and other required vendors (central imaging and laboratory)• Work closely with MIP manufacturing and regulatory groups to coordinate the selection and validation of a central radio pharmacy for the Phase I clinical site

Perform co-monitoring visits with vendor's CRAsContribute to the development of study documentation including, but not limited to protocols, clinical study reports, CRFs, and CRF guidelines. Oversee investigator selection and study site activities either directly or through management of CRO project teams. Work directly with CMC manager to create/review IMP label and set up a process for IMP distribution. Provide clinical input into the randomization system both in house and through the use of IWRS (taking into consideration logistical considerations at sites)Ensure that study documentation is maintained according to FDA guidelines and SOPs both on-site and in-houseContributed as a Clinical Operations representative in cross-functional initiatives, as assigned by management

Contribute to the successful planning and implementation of clinical studies through protocol review and development of study procedure manuals and case report forms Ensure compliance of study activities with FDA regulations, ICH guidelines, principles of Good Clinical Practice and Sirtris' Standard Operating Procedures Participate in all phases of clinical monitoring from site qualification to site closure visits; prepare site visit reports Assist with study site selection in collaboration with the Clinical Project Manager Confirm patient eligibility, communicate and document protocol violations, review and update site specific consent forms, document site progress, including patient accrual, via standard reports Assure integrity of clinical data with respect to accuracy, accountability, and documentation through review of case report forms, source documents, and medical records; manage reporting of adverse events and serious adverse events Ensure sites meet target enrollment and is within projected budget Maintain study documentation according to FDA guidelines and SOPs both on-site and in house Provide input to medical reports and IBs, when required, including data cleanup, listing review, and other input as necessary Prepare drug request forms and maintain awareness of drug lots and expiration dates; assist with drug supply forecasting; coordinate the distribution of clinical trial supplies to sites Provide technical support to clinical investigators and study coordinators with eCRFs and IWRS Maintain/develop a good level of scientific knowledge within the therapeutic areas under investigation Contribute to the review of existing and new clinical research SOPs. Communicate with other team members to ensure harmony of standards and procedures

Assigned to be the Clinical Project Manager for a Phase I, first in man clinical trialOrganize the off-site Kick-off meeting and the clinical site initiation visit and help prepare the slide presentations Perform all responsibilities for site initiations including site selection, preparation, monitoring, and close-out visitsAct as the primary contact for vendors including the clinical site, data management vendor and the central laboratory vendorIdentify, recruit, and evaluate investigators, perform clinical study assignments including initiation, training of centers, study site data monitoring, and collection of regulatory documentationParticipate in database closure and research report writing activitiesPerform co-monitoring visits with the CRO, including source document verification, regulatory document management and tracking, ICF creation and management, PI and study coordinator communicationMange the study clinical trial master file and online filing system, manage the project study timelinePrepare agendas and take minutes for weekly team meetings and review minutes from our vendor who is responsible for the weekly vendor team callsFacilitate team meetings in the absence of the Program ManagerLiaise with Regulatory Affairs, Project Management, Quality Assurance, Manufacturing and Pharmaceutics to organize regulatory documents and drug shipmentsResponsible for SOP development and review, databasing of CRFs and routing/resolution of all data queriesPossesses working knowledge of GCP/ICH/FDA regulatory requirements and leverages knowledge to resolve routine study issues

Phase I, Phase II and Phase III Recombinant Growth Hormone and Pancreatic Enzyme trialsRegulatory tracking system administrator; responsibilities includes setting up each study, adding all study related personnel, tracking CRFs, adding patient information and assigning users and groups Create and maintain master regulatory files and file all regulatory documentsCoordinate the full lifecycle of confidentiality agreements; track all Clinical contracts through to completionDocument decisions made in group meetings for all study teams and vendor meetings for clinical studies.Edit clinical documents in the ISIWriter Template formatLiaise with finance department to managing all clinical invoices for the departmentPerform listing reviews to identify discrepancies for the clinical teamManage scanning and archiving of all clinical documents

Assist the Vice President of Clinical Development and Medical Affairs and the Medical Director with travel arrangements, expense reports, and calendar managementManage the invoice tracking for all clinical vendorsOrganize the clinical department's central files room and organized an effective document sign out procedure