Line Management responsibilities including administrative oversight, professional development, performance appraisals, and mentoring/coaching of staff
Maximizes development of staff through guidance, coaching, training, and performance management
Provides leadership, direction and management to staff related to monitoring, enrollment and/or site management to ensure deliverables are met
Contributes to operational initiatives and continuous improvement
Uses metrics, dashboards, and reports to analyze staff performance for compliance, quality, operational and financial delivery
Serves as a point of escalation for internal and external customers
Reviews workload, utilization, productivity, and quality for staff in reporting chain
Manages staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level
Works closely within appropriate business unit/region to ensure staff performance on studies and correct deficiencies as identified by staff, clients, and auditors
Acts as a point of contact for performance related concerns for assigned staff related to monitoring, enrollment and/or site management
Provides operational oversight and guidance to support prioritization of activities, reviews and monitors the work performed, metrics compliance, and development of contingency plans, among others
May support fiscal management tasks of projects related to monitoring, enrollment and/or site management
Support the assessment of overall staff growth and actively participate in the selection and hiring process
Proactively works to ensure staff retention and turnover rates remain within expected levels
Ensures all staff follows required training and completes the required documentation
Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WI) and compliance with federal, local guidelines, and ICH GCP
Provides regular compliance updates to management accordingly
Manages the resource availability and assignment for direct reports, supporting direct reports who ensure assigned projects are suitably resourced and staffing needs are identified in a timely fashion, resolving potential resourcing conflicts to facilitate mutually beneficial resolutions
Liaises with resourcing management on active awarded and proposal project assignments
Participates in cross-organizational initiatives; champions change management and implementation of initiatives
Identifies needs and makes recommendations for process improvement and efficiencies
Supports staff in marketing activities, client presentations and proposal/Bid Defense development
Participates in audits of clinical trial management delivery and prepares others for participation in audits

Requirements

Bachelor’s degree or equivalent combination of education, training, and experience
Master’s degree or life sciences degree preferred
Familiar with Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements
Familiar with monitoring, enrollment and/or site management procedures preferred
Familiar with project risk and issues management
Ability to anticipate and address critical issues; and develop contingency plans in a proactive manner
Experience interacting with key stakeholders and sponsors, including experience handling conflict and difficult conversations
Ability to persuade and influence at all levels, demonstrate strong negotiation skills, organizational skills, and problem-solving skills
Familiar with management of utilization, resources, hiring targets and productivity metrics
Ability to teach, train and mentor employees of all levels to achieve project, departmental, personal, and organizational goals
Familiar with financial concepts as related to forecasting, budgeting, and proposal generation
Requires strong presentation, written and verbal communication, documentation, and interpersonal skills as well as a team-oriented approach
Demonstrate understanding of the workflow process, roles and responsibilities of multiple functional areas, and ability to work across those functional areas
Proficiency in Microsoft Office Suite (Outlook, Teams, Word, Excel, PowerPoint, etc.)
Demonstrates ability to leverage Analytical Data Visualization Tools to drive performance, operational efficiency, and decisions
Knowledge of Lean Six Sigma preferred

Benefits

Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time

Applicant Tracking System Keywords

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

Hard Skills & Tools

Good Clinical PracticeICH E6 (R2) Guidelinesproject risk managementperformance managementfinancial forecastingbudgetingproposal generationLean Six Sigmastaff trainingstaff mentoring

Soft Skills

leadershipcoachingnegotiationproblem-solvingorganizational skillscommunication skillsinterpersonal skillsconflict resolutioninfluencing skillsteam-oriented approach