Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.
Data Management (DM) are seeking a Clinical Data Team Lead (CDTL) to work within our FSP model in the UK. The CDTL will act as the lead data manager for one or more projects, dedicated to one client. The successful individual may lead all data management activities for individual, limited volume/complexity studies with support from senior team members.
Job Responsibilities:
Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks. Acts as a liaison to the Project Lead and/or client as required and communicates with management regarding all DM activities within their studies. Develops and maintains data management project documentation files; performs independent reviews of data management deliverables following documented clinical DM guidelines. Develops and delivers study specific training for DM project staff. Produces project-specific status reports for management, Project Lead and/or clients on a regular basis. Monitors study metrics. May participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required. Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to Project Lead and management and assists with the Contract Modification process. Mentors junior level staff on all associated tasks within a study. Assists with the administrative and financial management of allocated projects. Performs all assigned data management activities independently and efficiently, with attention to quality.
Education and Experience:
Bachelor's degreePrevious experience that provides the knowledge, skills and abilities to perform the job (comparable to 2+ years in a similar position)
Knowledge, Skills and Abilities:
Experience as a Clinical Data Team Lead (or similar)Strong experience with SDTM (essential) - test packages, specs, define.xml, pinnacle 21 reports and creation of DTA.Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations.Ability to use interactive computer programs.Good written and verbal communication skills with a strong command of the English language and grammar. Good organizational, analytical/problem solving skills and attention to detail.Ability to work productively with minimal supervision Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data.Strong customer focus and excellent interpersonal skills.Proven flexibility and adaptability.Ability to work in a team environment and independently as needed.Ability to train and direct study team.Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands.
This role has no line management responsibility.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com