Data Management Team Lead
- Employer
- Simbec-Orion
- Location
- Remote, United Kingdom
- Salary
- Competitive
- Start date
- 5 May 2021
- Closing date
- 4 Jun 2021
View more
- Discipline
- R & D , Bioinformatics
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
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Job Details
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.
Summary of the Position:
We are looking for a Data Management Team Lead to join our Biometrics department.
You will take responsibility for leading the Data Management team, including line management, mentoring, process improvement and resource planning. Additionally, the role will provide Data Management support on clinical studies, working with the team across all aspects of the study from eCRF design, review and testing, all aspects of data review and database lock procedures.
Key Accountabilities:
Minimum Requirements:
Essential:
Desirable:
Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.
Summary of the Position:
We are looking for a Data Management Team Lead to join our Biometrics department.
You will take responsibility for leading the Data Management team, including line management, mentoring, process improvement and resource planning. Additionally, the role will provide Data Management support on clinical studies, working with the team across all aspects of the study from eCRF design, review and testing, all aspects of data review and database lock procedures.
Key Accountabilities:
- Manage the flow of work and resource within the allocated Data Management team to allow the team to adhere to agreed study timelines and flag potential problems to department head and Project Manager.
- Leads/Participate at sponsor meetings, including Bid Defence Meetings Kick-off Meetings and audits, to provide input from a Data Management perspective and to present the Data Management processes as required.
- Support department head in the review and update of SOPs and lead process improvement initiatives.
- Line management of assigned empoyees.
- Provide in-house training, development and coaching and mentoring for assigned employees and other colleagues.
- Ensure sponsors and internal team members are aware of the implications of relevant regulatory guidance.
- Communicate clinical data and quality issues to the Head of Department.
- Provide solutions to issues that arise during the conduct and analysis of the study.
- Other relevant tasks as assigned by their manager with appropriate training.
Minimum Requirements:
Essential:
- Minimum A levels (or equivalent)
- Previous experience of within a Lead Data Management Role within the Pharmaceutical industry or a Clinical Research Organisation
- Experience in t eam resource planning and task allocation
- Experience in Sponsor meetings including Kick-off Meetings and audits
- Experience in Bid Defence Meetings, including preparatory and follow up meetings
- Ability to lead process improvement activities
- Good understanding of clinical trial budgets
- Experience in identifying and tracking Out Of Scope activities
- Excellent written and verbal communication skills in fluent English
Desirable:
- A degree or equivalent in any science/maths subject or overseas equivalent
- Knowledge of programming activities including database build and SAS programming
- Experience with Oracle InForm eCRF
- Experience of working on oncology and rare disease clinical trials
- Experience in developing training and mentoring programs
Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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