Manager/Sr. Manager, Clin Ops – FSP

Role Overview

• 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
• Escalates 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
• Manages 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

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
• 1+ year of leadership responsibility
• 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, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
• Demonstrated ability to evaluate medical research data
• Strong organizational and negotiation skills
• Strong attention to detail
• Advanced written and oral communication skills
• Good knowledge of English language and grammar
• Demonstrated use of computer to include data entry, archival and retrieval
• Ability to travel as needed
• Excellent team player with team building skills
• Excellent interpersonal and conflict resolution skills
• Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
• Solid knowledge of medical/therapeutic areas and medical terminology

Tech Stack

• Google Cloud Platform

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short
• and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount