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

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trials monitoringdata entryarchival and retrievalevaluation of medical research datarisk-based monitoringtraining program developmentperformance appraisalKPI evaluationSOPsWPDs

Soft Skills

leadershipmentoringsupervisory skillsorganizational skillsnegotiation skillsattention to detailwritten communicationoral communicationinterpersonal skillsconflict resolution

Certifications

Bachelor's degreeICH/GCP certificationFDA guidelines knowledge