Description
ROLE SUMMARY
ROLE RESPONSIBILITIES
- Works closely with department roles, assigned mentor, and cross-functional study team members to manage the development cycle of data capture solutions that support the quality and timely delivery of data required per standard and study specific data review plans.
- Solves moderately complex problems related to database build and implementation
- May aid with solving problems outside of own department
- Oversees operational activities/projects of professional Work Teams to support short-term Department goals.
- Leads internal initiatives, working with other roles within CDS to improve processes. Represents Database Management on CDS initiatives.
- Complies with applicable SOPs and work practices
- Serve as a project management resource to the study teams for developing and implementing database development project plans.
- Ensure proper planning of study activities in DBM and proactively alert risk and plan mitigation.
- Independently, perform Impact analysis for proposed solutions to existing tools and processes and convey the same to technical and non-technical stakeholders.
- Participate in (COMPANY NAME) Standards meetings as appropriate
- Ensure compliance always
- Ensure seamless functioning and collaboration of CDS activities between the DBM and Clinical Data Scientist functions.
- Assess impacts of Change Control and develop mitigation plans for emerging risks and issues.
- Identifies existing process/product improvements
- Develops innovative, advanced new concepts that improve processes / products across own and related disciplines
- Takes appropriate risks to achieve desired result
BASIC QUALIFICATIONS
- Bachelor's degree in Life Sciences, Computer Science, or equivalent
- Minimum of 5 years of relevant project management experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions
- Strong project management, communication (written and oral), decision-making, influencing, and negotiation skills
- Familiarity with Electronic Data Capture systems, Clinical Data Management Systems/relational databases (e.g. Oracle InForm and Data Management Workbench, MS SQL Server or MS Access) and data visualization tools (e.g. Spotfire, J-Review)
- Experience with MS Project or other enterprise project management tools
PREFERRED QUALIFICATIONS
- Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.)
- Understanding of regulatory requirements and relevant data standards; CDISC knowledge and experience are preferable
- Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
LI#PFE
Purpose
Breakthroughs that change patients' lives... At (COMPANY NAME) we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, (COMPANY NAME) is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Medical
LI-PFE