As a member of Excelya’s Operational Leadership team, reporting to the Head of Operations, you will have overall responsibility for customer deliveries within the scope of Data Management for FSP, Consulting and Full Service Data Management projects across Europe. Your knowledge and experience will help guide key company decisions and growth as you interact with Excelya teams and our customers.
Oversee the planning and execution of all data management activities across multiple clinical trials and FSPs.
Supervise full-time Global Data Managers assigned to their programs and execute associated hiring, onboarding, coaching and performance management responsibilities. Identify assignments for consulting staff and assess effectiveness of all staff as appropriate.
Evaluate the options for geographical expansion of the DM teams to support client projects.
This position will serve as the data management primary escalation point of contact for customers, and it is expected that at least 20% of the role will be spent working directly with customers to understand their needs and to better execute their studies.
Provide leadership and expertise to the company in relevant technical areas and cross-functional initiatives. This will include assessment of technical tools to support DM activities .Provide input and/or leadership into the development of departmental policies, processes, training, and/or standards.
– Ensure work is carried out to quality levels defined in our SOPs and service agreements
– Review and enhance procedures and tools to ensure that the overall quality of delivery meets regulations e.g. ICH E6 R2/R3 GCP, ICH E8 and industry adopted data standards such as CDISC, CDASH and SDTM and satisfies our customers
– Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11
– Ensure staff are appropriately trained and understand their roles and responsibility
– Support, manage, and mentor teams to deliver for Excelya
– Contribute to the development and maintenance of departmental policies, SOPs, procedures, training and standards.
– Instigate a continual review of process and procedures to be efficient in study delivery
– Apply the right level of staff to tasks to maximise margin without impacting time and quality
– Resource projects through their lifecycle to maximise margin without impacting time and quality
– Implement a structure that allows departments to work collaboratively together
– Implement KPIs and metrics to demonstrate to our organization innovation and performance progress
– Establish clear reporting tools to support internal performance to and inform our customers
Budgets and cash flow
– Review key projects and assignments monthly to ensure that margin targets and achieved
– Work with non-operations Excelyates to ensure invoices are promptly raised and any out of scope work is approved and funded by customers
– Prepare annual budgets and quarterly forecasts
– Be visible and available to customers
– Act as an escalation point for customer accounts and be involved in strategic governance meetings
– Support new project bid process with advice, support, and resources
– Participate/present in industry meetings like SCDM to raise the profile of Excelya
Profile & Requirements
– A minimum of Bachelor’s degree is required, preferably in a Scientific, IT or Mathematical discipline. Advanced degree (Master’s, PhD is preferred)
– At least 8 years’ overall experience in operational delivery within a pharma company and or a CRO
– At least 3 years CRO experience in an management position in a multi-country environment is essential
– Experience of managing global multi-site Data Management teams is desirable, experience of managing teams in Eastern Europe would be benefitial
– Expert understanding of the application of CDASH/CDISC in a real word environment
– Extensive experience of leading EDC and/or eSource studies
– Experience using standardized medical terminology, including MedDRA and WHODrug
– Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project. Experience in SAS would be a benefit.
– Leverage excellent communication and interpersonal skills to engage people in key decisions at group level and act as an ambassador to senior leaders in client companies and regulators
– You are perfectly capable of working in English and ideally capable in French and/or German
– In-depth knowledge of the clinical trial process and systems applications to support data management operations
– Thorough knowledge of time and cost estimate development and service pricing strategies
– Working knowledge of the regulatory obligation of the CRO industry with pharmaceutical biotechnological companies
– Excellent oral and written communication and presentation skills
– A high-energy individual who can support the fast-paced growth of our European expansion
This is a full-time position on a permanent contract, remotely based or ideally based in Boulogne-Billancourt or Freiburg with likely travel up to 25% of your time ( once Covid rules permit ).