Job Description :
Senior Clinical Study Manager
Location : Basking Ridge, NJ
Interview : Phone and F2F or Skype (Preferred Local)
Duration : 12+ Months
JOB DESCRIPTION :
Education:
A Bachelor''s degree in the Sciences is acceptable.
Candidates with a nursing diploma/assoc degree with substantial experience may be considered for this position.
Experience:
5 years relevant experience Study Management Team Leader - Oncology is required with a BSc, 3 years with a MS/MPH, or 2 years with PharmD/PhD/MD
Phase Ib/II/III Oncology trial experience strongly preferred
Global trial experience strongly preferred
Global Study Leadership of Pivotal NDA filing studies highly preferred
PMP, CCRA certifications desired but not required.
Experience working in both sponsor and CRO organizations strongly preferred
Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO CRA experience is preferred. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.
Working remote 1-3 days a week will be considered after a few weeks in the office.
Duties:
Multiple opportunities available for Global Clinical Operations Study Leader to successfully lead a high profile large Oncology study.
The Sr Clinical Operations Study Leader role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require the Sr. CSL to take the role of both operational strategy and study management - execution, in addition to the responsibility 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 plan provided by the CRO. Participate in site selection and site qualification with (study team and CRO
Lead the Study team along with contributing to operational delivery aspects of the protocol and lead document review & coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.
Take responsibility to ensure meeting logistics, agenda and minutes are in accordance with DS standards. At this level, the incumbent will be expected to be able to lead the cross functional study team. Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders to ensure cross functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc per the study plan. Oversee the CRO and provide timely input to ensure that the CRO-generated documents are created in a timely manner (communication plan, site monitoring plan, etc ahead of study start. Oversee CRO study start-up activities and coordinate with functional group to ensure that essential site documents are collected and sites are initiated per plan. Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings and investigator meetings and training.
Note that vendor management is not limited to the CRO, but includes ancillary vendors (e.g. translations, trial insurance, and central laboratory
Work closely and oversee CRO activities for study execution with CRO on a task / operational level per the project plan. Oversee CRF completion and monitoring; Triage, resolve or escalate study issues to the supervisor.
Oversee CRO study close-out. Liaise with internal Functions to ensure drug destruction process is implemented. Liaise with CRO to support database lock and review of TLG before and after database lock.
Ensure DS internal tracking systems are updated (e.g. Global Project Management System, GPMS
The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
A key focus will be the oversight of and interactions with CROs and other external vendors to ensure studies are conducted according to the timeline, budget and objectives set forth by the Study team.