Data Management Lead II (UK, Poland, Spain, Hungary, Romania)

The role can be flexibly based in Poland, Romania, Hungary, Spain, UK.

The Data Management Lead l provides leadership in all aspects of Data Management. Manages timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management’s single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, financial management and quality.The Data Management Lead l works under the guidance of their Line Manager and may receive additional direction/support from an experienced Data Management Lead or Subject Matter Experts. They may work as a co-DML with an experienced DML or work independently on less complex trials.

Main accountabilities:

• Provide leadership to ensure the project or program is completed within budget, schedule and according to contract specifications. Ensure the project/program is progressing according to quality standards, SOP's, ICH and/or other guidelines to fulfill regulations.

• Manage time, and understand financials, maintain focus on quality, balancing deadlines with ensuring high quality output maintenance of relevant data operations project documentation.

• Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave).

• In-Depth knowledge of electronic source data capture systems (e.g. ClinBase).

• Knowledge of the eClinical suite and additional tools and systems that can be integrated with a particular EDC system.

• (MyTrials, IVRS etc) and Reporting functionality within the EDC system).

• Thorough knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation.

• Effectively communicate to and manage internal project teams, external customers and third party vendors. Hold team meetings on a regular basis. Participate in client, investigator and team meetings. Ensure interdependencies are understood, anticipate potential barriers or issues, and put plan in place with appropriate countermeasures.

• Oversee contracted project delivery. Highlight issues/risks to delivery and mitigate risks for both Parexel and the client, developing contingency plans for the project (or providing input to PL). Accountable for quality control of project deliverables and timely delivery of projects.

• Manage appropriate project level resourcing of staff and staff assignments. Identify and request staff necessary for the project team.

• Review metrics reports regularly, determine the cause of any project overruns, track scope of ongoing work to identify and raise CIS in a timely manner.

• Participate in cross functional meetings and drive initiatives, participate in Business Development and BID Defense meetings as required.

• Prepare, participate in and follow up on audits/inspections.

• Collaboration with the Clinical team to review the ClinBase setup performed by the pharmacy, safety Laboratory team and Clinical Database Designer.

Ideal candidate will possess:

• Data Management experience in clinical research industry (CRO/Pharma).

• Proven record of coordinating and supporting project teams.

• Bachelor’s degree in a science or industry related discipline.

• Competent in written and oral English .

• Leadership skills that include: building and leading global (virtual) teams, ability to work effectively with and motivate virtual teams, ability to negotiate and influence in order to achieve mutually beneficial results, ability to conduct root cause analysis in business problem solving and process improvement development.

• Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.

• Sound awareness of relevant regulations, including ICH-GCP, 21CRF11.

• Excellent technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS.

• Excellent interpersonal, oral and written communication skills.

• Excellent presentation skills.

• Strong customer focus, ability to interact professionally within a client organization.

• Basic knowledge of SAS.