Senior Manager, Clinical Operations (FSP )

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Sr Manager - Clinical Operations – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As a Sr Manager - Clinical Operations, you will oversee, train, resource, coach and performance manage a team, which may be inclusive of various clinical operations focused staff. You will focus on end results using metrics and key performance indicators to lead performance. You will act as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. You will also work in collaboration with the leadership team for resourcing needs. What You’ll Do: • Manages staff, providing coaching, mentorship and work direction. • Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff. • Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company. • Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports. • Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Raises appropriately any issues which may impact project deliverables. • Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate. • Assures adherence to good ethical and regulatory standards. • Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required. • Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status. • Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable. • Participates in process improvement/development initiatives. • Ensures understanding and facilitation of the risk-based monitoring approach. • May provide input into bids and contribute to the procurement of new business where required. • Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. • Works closely with local client/sponsor teams to meet program KPIs and to support in the risk management and resolution of issues. • May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

Requirements: Bachelor Degree in Life Science is Preferred 12+ year of Experience in Clinical Monitoring, Trial Management, eTMF management, Onsite Monitoring related activities Should have experience in Managing CRAs, CTCs, Project Support Coordinators for More than 4+ Years Should have experience in managing one or multiple FSP Clients as Single Point of Contact Should have experience in Workflow Allocation, Performance Management, Quality/CAPA, Reporting related activities Should be willing to Travel to Clinical Trial Sites across India (up to 25% Travel) Knowledge, Skills and Abilities: • Advanced mentoring/leadership/supervisory skills • Excellent clinical trials monitoring skills; Remote and on-site • Demonstrated understanding of or ability to learn the company’s SOPs,