Manages, selects, trains, resources, coaches and performance management of respective staff, which may be inclusive of CRAs, PAs, RSMs and other clinical focused staff. Focuses on end results using metrics and key performance indicators to manage performance. May lead or contribute to initiatives that enhance the department’s performance or lead to process improvement across PPD. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to PPD SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.
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 managers and clinical team managers 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
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. 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.
Education and Experience:
Knowledge, Skills and Abilities:
Advanced knowledge of clinical trials monitoring; Remote and on-site
Demonstrated understanding of or ability to learn PPD 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
Effective written and oral communication skills
Good knowledge of English language and grammar
Competent 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
Ability to utilize problem-solving techniques applicable to constantly changing environment
Solid knowledge of medical/therapeutic areas and medical terminology