Department CRO Job posted on Nov 26 2025 Employment type C-C6-Confirmed-R D Executive Role Purpose Responsible for Management of Clinical Trial Areas of time Key Accountabilities Responsibilities 1 Project Management 45 Identify prepare and optimize project resources and schedule Review of Protocol ICF Clinical study report or any other study specific document Participate in site feasibility selection site initiation monitoring and close-out in accordance with applicable standard operating procedure SOP study specific plan and Good Clinical practice GCP Prepare and or review study documents e g project management plan communication plan monitoring plan note to file deviation and other study specific plan based on requirements Planning and execution of investigator meeting if required Review and or approval of site feasibility selection site initiation monitoring and close out report Assist provide project specific guidance training to study team site staff and investigator Ensure tracking follow up and resolution of site and or project specific issues in a timely manner Maintaining of study specific files in compliance of respective SOP study specific plan e g Trial Master file TMF Sponsor Site Master File electronic TMF etc Oversee and provide guidance to clinical trial assistant for the project specific duties Providing project specific training to study team vendors site staff etc Lead the Trial Team to ensure all trial deliverables are met according to timelines budget quality standards and operational procedures Constantly review the progress of studies and set benchmarks expectations during the study Provide periodic update on trial progress to the HOD and or Management Execution and or participation of study specific meeting or project specific management meeting Assist and ensure archival of projects as per archival SOP 2 Budget and Contracts 15 Preparation and or review tracking of project budget and get HOD and or Management approval after discussion Review and execution of project specific contracts Agreement Review of project specific invoice and co-ordination for site vendor payment 3 Vendor management 15 Identification selection and management of vendors clinical research organisations CRO s Co-ordination and or evaluation of vendor as per project specific requirements Manage study-related vendors and serve as the primary point of contact for contracted CROs labs logistic and any other study specific service provider 4 Quality and Regulatory 10 Ensure compliance to GCP protocol Study specific plan SOPs and applicable regulatory requirements Assist in planning of QC and or QA and or Regulatory inspection activities Preparation response and CAPA if required for any observations during QC QA Regulatory audit or inspection 5 Co-ordination with Cross functional team 10 Co-ordination and communication with internal and external cross-functional team e g bioanalytical CDM medical writing IP team QC QA regulatory affairs etc to ensure proper execution and conduct of the trial to meet the project deliverable as per timeline 6 Other 5 Providing project specific training to study team vendors site staff etc Preparation and or review of SOP To perform other duties as assigned by team incharge HOD Management Key Dimensions Financial DimensionsDeliver assigned clinical trial project on time within Scope and approved budget Ensure regulatory complinace TeamDirect Reports NIL Team Size 03 to 04 Qualification and Skillset Educational QualificationsMaster degree or equivalent in a Biomedical or Lifesciences M Pharm M B A Ph D Experience Type Nature Experience of handling of clinical trial from Various Therapeutics Area 8 to 10 years of experience in field of Clinical research Minimum 3 years of experience as a clinical project Manager Team Management Skills Technical CompetenciesCompetency in ICH-GCP and a solid interest in clinical research Previous experience with Phase 1 2 3 and 4 studies essential Monitoring experience Co-monitoring experience Understand technical scientific and medical information Understand clinical study budgets Effective Communication Key Dimensions Financial DimensionsDeliver assigned clinical trial project on time within Scope and approved budget Ensure regulatory complinace TeamDirect Reports NIL Qualification and Skillset Educational QualificationsMaster degree or equivalent in a Biomedical or Lifesciences M Pharm M B A Ph D Experience Type Nature Experience of handling of clinical trial from Various Therapeutics Area 10 to 18 years of experience in field of Clinical research Team Management Skills Technical CompetenciesCompetency in ICH-GCP and a strong interest in clinical research Previous experience with Phase 1 2 3 and 4 studies essential Monitoring experience Co-Monitoring experience Understand technical scientific and medical information Understand clinical study budgets Effective Communication