The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.

The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases.

We are currently looking for an enthusiastic and talented Senior Clinical Data Manager. This role is home-based anywhere in Romania. (Romanian Candidate Only and English CV required) 

Purpose

Carry out the required data management tasks on clinical studies or research projects within the clinical trial environment. Perform the role of Lead Data Manager on assigned studies with responsibility for the timely delivery of set-up, conduct and high quality final locked databases in accordance with the budget, Aixial’s contractual obligations and Standard Operating Procedures.

Responsibilities

Perform the following tasks, independently as the Lead Clinical Data Manager.

Study Setup

·         Review and input into relevant clinical trial documentation (e.g. protocol, Project Operational Plan, RAID log, Monitoring Plan) as per Scope of Work

·         Create and review advanced data strategies (incl. data flow)

·         Is responsible to initiate Data Management timelines

·         Is responsible to plan, manage and request resources for assigned projects

·         Prepare and/or review relevant trial level DM documentation (e.g. CRF design, DMP, SDS, CCGs, validation specifications, data transfer specifications …)

·         Prepare and/or review specifications for data listings, study specific status/metrics reports

·         Prepare and/or review eCRF/CRFs, clinical trial database design and validation check programming

·         Oversee and/or lead UAT and completion of associated documentation

·         Coordinate DB set-up and upgrades, including review of eCRFs, database design and validation check requirements

·         Prepare and conduct study specific EDC training for study team

Study Conduct & Close-out

·         Oversee and/or lead data listing review and query management

·         Oversee and/or lead the management and reconciliation of third-party data and SAEs

·         Oversee and/or lead the receipt, management, entry, QC and review of local laboratory reference ranges

·         Provide and oversee DM input into protocol deviations as needed

·         Oversee and/or lead DB freeze/lock related activities

·         Oversee and/or lead the archiving activities for study data and DM documentation activities

·         Support identification of the trends in the study assigned (eg: sites not compliant with data entry, queries resolution, …) and inform the PL accordingly.

Study Leadership

·         Lead assigned study or activities and where required, actively shadow study lead and deputize Lead CDM

·         Lead and participate in internal and external team communication

·         Ensure maintenance and filing of study documents

·         Follow up and escalate any data quality, budget, timelines and resource issues

·         Responsible for financial management of assigned projects, including revenue recognition, changes in scope, including liaison with PL/ Finance as needed

·         Lead and participate in client/vendor meetings and cover DM aspects

·         Provide input and estimates for budget requirements and resource; perform ongoing budget review

·         Ensure appropriate reporting of project status to internal and external stakeholders

·         Onboard extended DM team members

General

·         Ensure timely and accurate entry into relevant clinical study or research project/ departmental reporting systems (e.g. status, metrics, timesheet)

·         Maintain up to date knowledge for DM techniques, procedures and tools

·         Participate in departmental presentations and process improvement initiatives and visibly contribute to department development

·         Participate in and attend bid defense meetings for business development

·         Make recommendation for DM trainings on techniques and procedures; develop, review & deliver trainings

·         Train and/or mentor DM team or department members

·         Take on a formal SME role and provide expertise

·         Develop, review and deliver relevant departmental SOP/ Process Training

·         Prepare for, participate in and respond to audits where assigned as the Lead Clinical Data Manager

Required skills and qualities

·         Bachelor’s degree level qualification or equivalent experience is preferred

·         5 or more years of experience in clinical trial activities of clinical data management with experience of leading trials

·         Good organizational and problem-solving skills

·         Good oral and written communication and interpersonal skills

Technical skills

·         Good understanding of ICH/GCP and applicable regulations

·         Experience working with EDC systems (e.g. Rave, Viedoc, Veeva)

·         Experience in using Microsoft office and understanding of other reporting software

Languages

·         Fluent English: Read, Written, Spoken 

The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company. The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company. 

For more information on Aixial Group Recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - https://www.aixialgroup.com/join-us/

Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Aixial Group HR or Talent Acquisition Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.