Director, Clinical Data Management

remote from anywhere in Costa Rica

Contract

Job Overview
The Director, Clinical Data Management supports and implements the Clinical Data Management (CDM) strategy envisioned by the (Sr.) Vice President, Global Clinical Data Management as well as supports and implements the company strategy set forth by the Atorus Chief Executive Officer (CEO). Oversight includes regional direction of assigned operational areas and their corresponding financials for any given assigned model of CDM work such as Functional Service Provider (FSP), Full-Service and/or CDM Stand Alone for assigned sponsor(s). Ensures customer satisfaction with all services and deliverables provided. Provides support and guidance for the CDM department. Ensures CDM staff comply with Atorus and/or sponsor Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements.

Job Responsibilities

• Carry out department and company strategies, as required
• May participate in governance meetings, as required
• Oversight of assigned regional CDM model of work (FSP, Full-Service, Stand Alone)
• Manage assigned sponsor financials and ensures staff understands the areas they are responsible for
• Oversee staff monthly revenue recognition for assigned sponsors
• Participate in department and/or company initiatives
• Responsible for selection, training, development, and performance management of reporting staff
• Resourcing of staff and/or projects
• Ensure team deliverables are made on time and with high quality
• Ensure metric goals for assigned sponsor(s) are met or exceeded; troubleshooting areas that are in need of improvement
• Influence cross-functional leadership participation to ensure sponsor and/or project goals are effectively supported
• Partake in business development activities such as contracts, proposals, bid defense meetings, conferences, and works to obtain new business
• Ensure customer satisfaction with all services and deliverables based on customer feedback
• Participate in and/or contributes to Sponsor and/or Regulatory audits/inspections
• Create and/or review SOPs as applicable
• Ensure staff have completed and are adhering to departmental, company, and/or sponsor SOPs
• Perform other duties as required by the department

Qualifications And Education Requirements

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• 7 years of functional CDM work experience plus a minimum of 6 years of management experience preferred, or a combination of a minimum of 5 years of functional experience and a minimum of 5 years of management experience
• Additional relevant work experience will be considered in lieu of formal qualifications
• Broad knowledge of drug development processes
• Understanding of global clinical development budgets and relationship to productivity targets
• Knowledge of effective clinical data management practices

Preferred Skills

• Ability to coordinate and plan with global and/or ancillary counterparts
• Strong project management skillset
• Strong people management experience
• Excellent organizational skills
• Resourcing experience
• Strong communication skills, verbal and written
• Detail oriented
• Strong computer skills, including Microsoft Office and experience with data management systems
• Ability to effectively prioritize workload and deliverables
• Able to effectively make decisions, especially in cases of ambiguity and/or changing priorities with minimal support of upper management
• Experience with bid defenses and/or sponsor/relationship kick off meetings
• Flexible, team player