Group Director Study Operations, Oncology R&D, Early Clinical Oncology Location: Barcelona (On-site) / 3 days working from the office and 2 days working from home
The Group Director Study Operations is accountable for the management and development of a team of clinical operations specialists supporting the delivery of clinical studies and will lead or participate in functional activities supporting day to day business as well as change and improvement projects.
The Group Director Study Operations may also take on the responsibilities of the Director Study Leader for delivering development programs or leading multiple studies / single complex studies. The exact accountabilities will differ and so a high degree of flexibility and autonomy is required.
Typical Accountabilities
Management, development and career progression of clinical operations specialists
Recruitment and retention of staff
Ensure direct reports are appropriately trained and developed to comply with company and regulatory standards
Conduct ongoing performance management and complete the required steps of the performance management cycle
Resource management and efficient deployment of staff to clinical studies/programs
Oversight of quality and compliance of the group to ensure inspection readiness
Driving efficiencies and innovation across the operational skill group
Work closely with the Leadership Team to drive strategy and business performance
Development and maintenance of processes owned by the group
Driving productivity improvements and innovation within the group
Lead/participate/represent Study Operations in strategic work streams
In addition to the full line management accountabilities, the Group Director Study Operations may undertake responsibilities of the Director Study Leader, Early Oncology Clinical:
Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documents
With oversight from the Senior Director, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions
Leads the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality and scientific standards
Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate
Ensure sponsor oversight throughout the life of the study
Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriate
Responsible for planning and leading issue escalation and resolution
Provide input to forecasting and management of study/program delivery costs, resource and timelines
Accountable for the quality of study/program planning information into relevant planning systems
Mentors and supports development of individuals within the organisation
Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
Responsible for study or program level reporting of progress, risks and issues
Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
Provision to procurement clear specifications for study or program specific outsourcing
Review and operational approval of study or program specific contracts or work orders
Education, Qualifications, Skills and Experience
University degree in related discipline, preferably in medical or biological science, or discipline associated with Clinical Research
Significant experience in operational support and delivery in early clinical development
Experience of working with and delivering through strategic partners and 3rd party vendors
Excellent knowledge of ICH-GCP principles
Team orientated
Ability to lead, coordinate and prioritise multiple tasks and deliverables
Proactive approach
High degree of flexibility
Demonstrated verbal and written communication skills
Good negotiation and collaboration skills
Demonstrated interpersonal and problem-solving skills
Ability to manage change and actively seek and champion more efficient and effective ways of working
Some travel may be required
Experience in variety of academic/CRO/Sponsor organisations and countries
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