Manager, Clinical Data Sciences
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional Manager, Clinical Data Sciences to bring your passion to our team in Bucharest, Romania. We can consider home, office or a mix of the two.
You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
Maintains ultimate responsibility for all assigned projects and direct reports.
Responsible for mentoring and directly supervising direct reports along with other employees. Interviews, onboards, and mentors staff within the department or cross-functionally. Participates in initiatives for improving quality, utilization, efficiency, and resourcing. Represents the department both within Premier and externally with clients. Ensures the successful operation of projects and management of assigned personnel within Clinical Data Science. Serves as a member of the project team when assigned as the Lead or Program Data Scientist, with the responsibility for ensuring that all captured data follow the rules outlined by the protocol and departmental plans. Also responsible for documentation required for preparing and completing study databases and for upholding the quality of process execution and evidence.·
Serves as primary Clinical Data Sciences contact in assigned studies and ensures that data cleaning is performed in a consistent way between team members
· Coordinates all tasks within the data science process between different team members from database development to database lock
· Prepares data science plans, data entry guidelines, data science reports and other documents required for preparing and completing databases
· Supports database development activities and coordinates database amendments in collaboration with the database development team
· Provides leadership and advice to Data Coordinators (DCs) and trainees on Clinical Data Science procedures, SOPs, ICH-GCP
· Provides and/or co-ordinates training and mentoring of DCs and trainees
· Helps to assess DC performance and execute annual appraisals, monitors career development, and performs end-of-probationary-period reviews
· Onboards, trains, and evaluates new employees to facilitate integration into the department and to reach target utilization in a timely manner
· Supports department management in resource planning and allocation; hiring and management of data management staff; and achievement of department financial goals
· Directly manages a team of Lead Data Scientists and other Clinical Data Sciences staff as assigned
· Supports business development activities by participating in project costing estimates, proposal reviews/change order management and proposal defenses · Acts independently as a representative of Clinical Data Sciences in audits/inspections
· Participates in process improvement initiatives including SOP writing and revisions
· Represents Clinical Data Sciences cross functionally in corporate initiatives · Engages in recruitment for the department
· Leads/participates in task force groups that impact on the team
- · Provides oversight of data management project progress and financial status including resolution plans for unexpected challenges
- Bachelor’s degree or above (preferably in a Life Science); post-graduate degree prefered·
8-12 years mastery in Data Management experience, with at least 3-7 years ofsupervisory/management experience·
- Experience working across Clinical Data Management Systems and in-depth knowledge of at least one, preferably Medidata Rave and DataLabs EDC· Familiar with all phases of a study, e.g., pre-award, study startup/database setup, maintenance, and lock·
- Knowledge of data mining and the application of data standards·
- Knowledge of statistical principles and analysis·
- Strong presentation skills