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Clinical Operations Director

2 weeks ago

Pretoria, Gauteng, South Africa Ananzi Full time

At Ananzi, we are a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development and technology solutions across more than 20 therapeutic areas.

Job Overview:

The ideal candidate will manage a defined group of locally/centrally/regionally or globally based Site Readiness employees to ensure consistent, timely and high-quality delivery of regulatory, start-up and maintenance activities.

Responsibilities:
  • Collaborate with peers across the organization to achieve client-centric delivery in a matrix organization.
  • Work closely with all stakeholders within Site Readiness.
  • Mentor and advise staff in their day-to-day work.
  • Evaluate staffing and resourcing needs to ensure maximum staff utilization.
  • Assign team members to projects as required, based on experience and availability.
  • Interviews, evaluates, and recruits new staff as required while providing recruitment and retention initiatives for existing staff.
  • Determine staff training and development needs and ensure requirements are met.
  • Manage employee performance and employee development in a proactive manner.
  • Responsible for detailed performance review and management of assigned direct reports, including Annual Performance Management and Development (PMD) and Individual Development Plan (IDP).
  • Promote, review, and evaluate quality and performance metrics (individual and/or project specific) and ensure these are adequately documented and communicated.
  • If needed, put adequate actions/mitigation plans in place.
  • Contribute to the development of the group through participating in process improvement initiatives.
  • Ensure project deliverables are completed within agreed project specific timelines and in accordance with sponsor expectations and in compliance with SOPs and/or other quality and regulatory requirements.
  • Serve as an issue escalation point for concerns either from the external/internal project team members or other staff.
  • Participate in client-hosted audits (for completed/active project(s)) and audit responses, attending project specific audits and pre-qualification audits.
  • Support Business Development, including providing information for RFI and RFP responses, and bid defense meetings.
  • Attend bid defense meetings if required.
  • Review financial performance of allocated employees (which may include but is not limited to: resource assignment, revenue forecast and recognition, pricing, budgets, and profit margins).
  • Oversight of transactional clients.
  • Coordinate and Lead Project/Country Reviews.
  • Maintain awareness of current regulatory legislation, guidance and practice related to country delivery.
  • Evaluate the impact of clinical/regulatory changes on business operations and oversee internal regulatory intelligence database updates.
  • May advise on country strategy for project delivery and regulatory strategy.
  • All other duties as needed or assigned.
Qualifications:
  • University/college degree or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Knowledge of financial control procedures (e.g., costing systems, time reporting).
  • Working knowledge of project management/line management processes, preferably regarding study start-up.
  • Knowledge of time and cost estimate development.
  • Working knowledge of ICH Guidelines and GCP including local and/or international regulatory requirements for the conduct of clinical development programs.
  • Broad knowledge of drug development process and client needs.