Senior Clinical Study Manager (Office Based) - NCR
The incumbent will be responsible for ensuring the delivery execution ofclinical studies in one or more geographic regions, in adherence to GoodClinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs),Food and Drug Administration (FDA) regulations/EU Directive, and InternationalConference on Harmonization (ICH) guidelines.
A key focus will be the oversight of and interactions with CROs and otherexternal vendors to ensure studies are conducted according to the timeline,budget and objectives set forth by the Study team.
The Senior Clinical Study Manager role is primarily a tactical studydelivery role, reporting into an Associate Director (or above) responsible forOperational Study Strategy. This position may require the Sr. CSM to take therole of both operational strategy and study execution, in addition to theresponsibility of managing 1 to 2 direct reports
Develop project cross-functional, integrated study plan to study start up(in-house) and validate and manage to the overall study implementation planprovided by the CRO. Participate in site selection and site qualification with(study team and CRO).
Take responsibility to ensure meeting logistics, agenda and minutes arein accordance with DS standards. At this level, the incumbent will be expectedto be able to lead the cross functional study team. Act as the project managerof the clinical study team to liaise and coordinate with internal stakeholdersto ensure cross functional integration and delivery of items (eCRF, EDC, IXRS,Quality Oversight Plan etc) per the study plan. Oversee the CRO and providetimely input to ensure that the CRO-generated documents are created in a timelymanner (communication plan, site monitoring plan, etc) ahead of study start.Oversee CRO study start-up activities and coordinate with functional group toensure that essential site documents are collected and sites are initiated perplan. Coordinate with the CRO to prepare and execute meetings including Vendorkick-off meetings and investigator meetings and training.
Work closely and oversee CRO activities for study execution with CRO on atask / operational level per the project plan. Oversee CRF completion andmonitoring; Triage, resolve or escalate study issues to the supervisor.
Oversee CRO study close-out. Liaise with internal Functions to ensuredrug destruction process is implemented. Liaise with CRO to support databaselock and review of TLG before and after database lock.
Responsible for management of CRO performance to ensure adherence toscope of work within timelines and budget at a task level. Specifically trackshort-term operational study timelines and monitor operational performancemetrics trough the life of the study; Identify issues and propose solutions.Proactively assess potential risks to the study and propose mitigation plans.
Monitor study budget against trial progress and bring deviations to theDelivery Lead (Director/Assoc Director). Review and approve Vendor invoices,including investigator grants and pass through costs.
Provide oversight of the CRO to ensure compliance with quality measures.Contribute toward the creation of the Quality Oversight Plan (QOP) and take aleadership role in ensuring study team adherence to the QOP. Specificallyconduct quality oversight monitoring visits as outlined in QOP. Additionalresponsibilities include review and documentation of CRO-generated reports suchas trip reports, protocol deviation reports, and analysis of site metricreports. Be able to identify areas of concern and either resolve, proposesolutions, or bring to the attention of the supervisor. Coordinate and liaisewith audit activities
Provide oversight of the transmittal of trial and site level documents tothe Document Control Center (DCC) in support of the Trial master File (TMF).Reconcile the CRO-generated TMF document trackers with the document archive.Identify and resolve issues with the reconciliation.
In-house office position that may require occasional travel (global).
- A Bachelor’s degreein the Sciences is acceptable.
- Candidates with anursing diploma/assoc degree with substantial experience may be considered forthis position.
- 5 years relevantexperience is required with a BSc, 3 years with a MS/MPH, or 2 years withPharmD/PhD/MD
- Clinical studies,global regulatory issues, CRO operations, and compliance practices
- Interactsappropriately with high levels of internal and external stakeholders (e.g.,CROs); focuses on developing and building strong relationships
- Demonstratesappropriate level of understanding and application of internal and externalcompliance practices and global regulatory bodies and inspections
- Demonstrates abilityto manage all points of the clinical project, particularly complex projects
- Supports andeffectively multi-tasks different and complex assignments and responsibilities
- Investigates anddetermines solutions to difficult, problematic situations; escalates issues asnecessary.
- Effectively managesand leads study teams within the matrix of the organization; provides coachingand training
- Sound understandingof the concepts and applications of clinical research, medical terminology andother disciplines involved in drug development. Proficiency in computerapplications such as Microsoft Word, Excel, and PowerPoint. Strong oral andwritten communication skills.
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