Follow all applicable departmental Standard Operating Procedures and Work Instructions.
Complete day-to-day tasks ensuring quality and productivity.
Execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols.
Track and report metrics as determined by management according to required timelines.
Proactively identify opportunities for process improvements and participate in implementation.
Ability to mentor and train others.
Manage clinical systems
Maintain study databases (CTMS, IWRS, EDC etc.)
Track and follow up with CRAs for outstanding issues
Support in generating the study specific reports.
Manage internal/external communications
Assist in ensuring training compliance for study teams
Assist in study payments (Site and Vendor)
Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support; including data related to Clinical, SU, and VM.
Centralized Study Spec I are expected to take a leadership role in ensuring a successful partnership with other support groups, Centralized Study Spec I are expected to help remove barriers and to facilitate success.
May serve as the Centralized Study Spec I on projects where there is more than one Centralized
Delivery Associate or Sr Centralized Delivery Associate (provide guidance, facilitate teleconferences, task review, task delegation)
Actively support compliance metrics including CTMS, and overall project health
Update timelines and milestones within MS Project, CTMS, project governance tool, and other trackers which may include updates for applicable functions. Escalate when timelines are at risk.
Can draft or assist Project Lead / FL with project plans and coordinating review, feedback, and execution between study team (functional leads) and client
May assist with additional cross-functional tasks according to project needs
Can draft or assist Project Lead / FL with project plans and coordinating review, feedback, and execution between study team (functional leads) and client
May assist with additional cross-functional tasks according to project needs
Update timelines and milestones within MS Project, CTMS, project governance tool, and other trackers which may include updates for applicable functions. Escalate when timelines are at risk.
Additional responsibilities (Centralized Study team may perform below activities)
Facilitate study team communication & collaboration by attending & setting up team meetings for all functions, as needed.
Facilitate and document meetings with relevant tools in internal and external calls and ensure they are distributed and documented in accordance with study requirements
Vendor Management oversight
Walk-In-Interview Date : 28th September 2024 , Saturday
Time : 10 AM - 2 PM
Venue : MSR Vaishnavi 29, Union St, Near Cubbon Park Metro Station, Shivaji Nagar, Bengaluru, Karnataka 560001, India
Note : Candidates already interviewed for Centralized Delivery Role between 3rd Aug - 27th Sept will not be allowed.
Fortrea is a multinational contract research firm (CRO) that offers services to improve health . Providing all-inclusive CRO services for over three decades. With more than 20,000 innovative thinkers, we are dedicated to enabling healthcare solutions that can change people's lives.
By utilizing our extensive knowledge of clinical trials and our enthusiasm for scientific rigor, we assist in navigating the challenges associated with clinical research. We have the flexibility and self-assurance to respond to difficulties that arise. Our team consists of creative problem solvers that are dedicated to assisting you in connecting patients, caregivers, and healthcare providers with innovative concepts and tried-and-true treatments.
At Fortrea, innovation influences problem-solving techniques, clinical trial design and implementation, and patient recruitment strategies. Patients demand our finest work, so we apply insights to push the envelope and challenge the status quo, informed by data and real-world experience. Because of the permission-to-try mentality that Fortrea's leadership has fostered, our teams are empowered to always look for new and improved methods to support our partners in delivering life-saving healthcare solutions to the world as swiftly and effectively as possible.