Senior Data Team Lead
A job vacancy for a Senior Data Team Lead has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.
- Providing leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming.
- Managing the delivery of all relevant data operations activities from database setup through database lock and data transfers.
- Coordinating the relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met - specifically in terms of timeliness, financial management and quality.
- Providing leadership to ensure the project or program is completed within budget, schedule and according to contract specifications. Ensuring the project/program is progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfil regulations including oversight.
- Must manage time, and understand financials, maintain focus on quality, balancing deadlines with ensuring high quality output).
- Reviewing metrics to determine risks and risk mitigation plans as required.
- 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.
- Accountable for quality control of project deliverables and timely delivery of projects.
- Managing appropriate project level resourcing of staff and staff assignments. Identify and request staff necessary for the project team.
- Ensuring information entered into management systems is accurate and updated on a regular basis.
- Reviewing metrics reports regularly, determine the cause of any project overruns, track scope of ongoing work to identify and raise CIS in a timely manner.
- Participating in cross functional meetings and drive initiatives, participate in Business Development and BID Defense meetings as required.
- Preparing, participating in and following up on audits/inspections.
- Participating in meeting with Business Development / PFD / PL to understand the scope of the contract and any Master Service Agreement in place for the client.
- Collaboration with the Clinical team to review the ClinBase setup performed by the pharmacy, safety Laboratory team and Clinical Database Designer.
- Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave).
- Thorough knowledge of electronic source data capture systems (e.g. ClinBase)
- Thorough knowledge of the eClinical suite and additional tools and systems that can be integrated with a particular EDC system (MyTrials, IVRS etc ) and Reporting.
- Thorough knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation.
- Thorough knowledge of all activities during Study Maintenance and Database Lock.
Skills and Requirements:
- Bachelor's degree and / or other qualifications in a science or industry related discipline.
- Substantial experience in clinical research.
- Proven record of leading project and program teams in a technical/programming or data processing environment.
- Strong understanding of cross functional activities.
- Strong customer service focus.
- Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and the company's SOPs and study specific procedures.
- Strong customer focus, ability to interact professionally within a client organisation.
- Understanding of the company's project financial tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
- Commitment to quality.
- 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.
- Basic knowledge of SAS.
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams at +44 203 854 3893 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.