Clinical Operations Manager

Ortolan Group
10 Jan 2018
09 Feb 2018
Contract Type
Full Time
Clinical Operations Manager O4 Research is a successful Clinical Research Organisation (CRO), providing outsourced clinical research services to pharmaceutical, biotechnology, medical device and consumer health industries. We specialise in the strategic planning, set-up and conduct of Phase II-IV clinical trials and non-interventional studies across the UK, Ireland and Europe. O4 Research is entering an exciting new stage in its development and is seeking to expand the Belfast based team. We are currently recruiting for a Clinical Operations Manager to join our team on a permanent basis. Job Summary Responsible for line management of clinical operations team members, with particular emphasis on teamwork, quality and compliance with project plans, timelines and budget. Responsible for performance management of direct reports, perform skill-gap analysis, identify training needs to foster high level of performance ad proactively manage/resolve performance issues. Monitor and track KPIs for the team and management of resource, quality, metric and study deliverables. In collaboration with the leadership team, input and contribute to ongoing development of process improvements and best practices in operational and performance excellence. Key Responsibilities Maintain a positive and results-orientated work environment, communicating to the team in an open, balanced and objective manner, in line with the company's vision, values and strategy. Effectively communicate management strategies, procedures and policies in conjunction with leadership team and ensure these are followed to guidelines. Demonstrate high ethical behaviour at all times, whether dealing with colleagues, clients, vendors, healthcare professionals or patients. Co-ordinate with leadership to ensure efficient allocation of resources to assignment of activities and develop FTE forecasts to support study deliverables. Continuously assess performance and metrics, and ensure that quality deliverables are provided on time and within budget. Manage and assess/mitigate risks and help plan timelines for deliverables. Oversee and report progress against objectives whilst ensuring adherence to timelines and budget. Develop and maintain collaborative relationships with investigational sites and KOLs. Maintain good working relationships with internal and external clients and ensure opportunity for acquiring additional new business. Identify training needs and assist in the conduct of training, development and/or mentoring of junior team members and ensure staff are trained in GCP, SOPs and all applicable laws/regulations of each country in which we are conducting the trial. Serve as primary communication/escalation point for CPMs. Support the management of audits and regulatory inspections and create an audit/inspection ready environment Must have skills and qualifications · Proven clinical trial project management and leadership experience. · Relevant clinical research experience within Clinical, CRO or pharma industry. · Life Sciences/Scientific Degree preferred. · Proven ability to develop and update work practices and excellent attention to detail · Highly effective organisational, time and people management skills. · Desire for success and both results and customer focused. · Proven analytical thinking and decision-making skills. · Strong and proven client engagement. · Proven project management, communication and negotiation skills Candidates will need to have current and valid eligibility to work in UK and Ireland in order to be considered for this role Job Type: Full-time By applying for this role, your details will be sent to Ortolan People, who are acting as consultants for the hiring company. Ortolan People are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.