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 specialistsRecruitment and retention of staffEnsure direct reports are appropriately trained and developed to comply with company and regulatory standardsConduct ongoing performance management and complete the required steps of the performance management cycleResource management and efficient deployment of staff to clinical studies/programsOversight of quality and compliance of the group to ensure inspection readinessDriving efficiencies and innovation across the operational skill groupWork closely with the Leadership Team to drive strategy and business performanceDevelopment and maintenance of processes owned by the groupDriving productivity improvements and innovation within the groupLead/participate/represent Study Operations in strategic work streamsIn 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 documentsWith oversight from the Senior Director, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactionsLeads 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 standardsAccountable 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 appropriateEnsure sponsor oversight throughout the life of the studyDevelops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriateResponsible for planning and leading issue escalation and resolutionProvide input to forecasting and management of study/program delivery costs, resource and timelinesAccountable for the quality of study/program planning information into relevant planning systemsMentors and supports development of individuals within the organisationContributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaboratorsResponsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programsResponsible for study or program level reporting of progress, risks and issuesLead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality AssuranceProvision to procurement clear specifications for study or program specific outsourcingReview and operational approval of study or program specific contracts or work ordersEducation, Qualifications, Skills and Experience University degree in related discipline, preferably in medical or biological science, or discipline associated with Clinical ResearchSignificant experience in operational support and delivery in early clinical developmentExperience of working with and delivering through strategic partners and 3rd party vendorsExcellent knowledge of ICH-GCP principlesTeam orientatedAbility to lead, coordinate and prioritise multiple tasks and deliverablesProactive approachHigh degree of flexibilityDemonstrated verbal and written communication skillsGood negotiation and collaboration skillsDemonstrated interpersonal and problem-solving skillsAbility to manage change and actively seek and champion more efficient and effective ways of workingSome travel may be requiredExperience in variety of academic/CRO/Sponsor organisations and countries
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