Centralized Study Spec I

2 months ago

Bengaluru Karnataka, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

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.

Other duties/activities as assigned by study management team, but not limited to:
Manage clinical systems

Manage study documents and support eTMF management

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.

Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive, as applicable.

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 TMF, 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

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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