Job Description

Work Schedule

Other

Environmental Conditions

Office

📍 This is an 11-month contract position based in Bangalore and requires candidates to work in the afternoon shift

• Coordinates, oversees and completes functions on assigned trial activities detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Follows up for resolution of findings and raises whenever vital.
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Bring ups in cases of variances (overburn/underburn) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSC’s free capacity
• Supports the maintenance and oversight of study specific documentation and global support with specific systems, tools and trackers to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system.
• Pro vi des sys tem (i. e C TM S, Or acle Acti vate & eTMF) su pport by man aging the access r equ es ts, supervising s tu dy l evel do cu men ts, main taining au dit r eadin ess and presenting the n on -compli an ce to the s tu dy team and suggesting resolution
• Per for ms adminis tr ative tas ks on assi gn ed tri als in clu din g, but not li mi ted to: ti mely pro cess ing of docu men ts s ent to CRG's Cli ent eTMF as required, per for ming CRG's Cli ent eTMF r evi ews and coo rdin ati ng and proposing is sue r eso lu tio n, per for ming mass mailin gs and co mmun ications as n eeded, pro vi ding docu men ts and r epor ts to in tern al team members.
• Su ppor ts s ch edul ing and o rganiz ation of cli ent andor in tern al meetin gs wi th co mpl etion and dis tri bu tion of r el ated meeting mi nu tes and follow up for closure of action items, if required.
• Ex por ts and r econ cil es s tu dy metri cs r epor ts, and if required analyzes and identifies issues (if involved in a Lead role
• Maintains and regularly checks for correctness of vendor trackers.
• Drives and coordinates the compilation of Investigator Site File (ISF) template, pharmacy binder with instruction from the Clinical Team Manager.
• Attends Kick off and Project Launch meetings and takes notes when required, supports initial study set-up.

Edu cation and Ex peri en ce

Hi gh / S econ dary s chool di plo ma/ equi val ent and r el evant for mal academic / vocation al qu al ifi cation

Techni cal posi tio ns may r equire a cer ti ficate

Pr evious experi en ce th at pro vi des the kno wl edge, s kil ls, and abili ti es to per form the job (co mpar able to at l east 0 to 4 years )