Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Analgesia, Neuroscience, Oncology, Dermatology, Pediatrics, and Rare Diseases.
We’re looking for an energized Associate Manager, Clinical Data Sciences to join our team! This is an exciting opportunity to join a dynamic and innovative team and grow with a forward-thinking organization, changing to course of medicine.
Working at Premier Research means being an individual - you will be recognized for what you do and the impact made. You will be working in a friendly environment with colleagues who are genuinely supportive, regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company. Come and be part of it!
As an Associate Manager Clinical Data Sciences, you will have the opportunity to serve as a member of the project team with the lead responsibility for reviewing CRFs, data listings, and databases to ensure that all captured data follow the rules outlined by the protocol and data management plan. You'll also prepare data management plans, data entry guidelines, data management reports and other documents required for preparing and completing databases. Where a Biometrics Project Manager is allocated on a study, you'll act as the Data Operations point of contact for all data management responsibilities when designated as the Data Management Team Leader (Core Team Representative). You will also be able to be a Line Manager and Mentor to a small group of less experienced team members.
What you’ll be doing:
- Coordinate and act as point of contact for all data operations responsibilities related to Data Management for multiple studies
- Participate in resources allocation and utilization issues with the management team for data management
- Manage personnel (Assoc. Data Coordinators, Data Coordinators and Senior Data Coordinators) with respect to data management skill development & recruitment, training, career development, issue resolution, performance management, billing practices, and adherence to PRG SOPs/Guidelines and GCP standards; lead, Mentor and train junior staff in an aspirational and empowering working environment
- Prepare data management plans, data entry guidelines, data management reports and other documents required for preparing and completing databases
- Review draft protocols and CRFs for potential data collection and representation, database structure or data entry problems, and provide feedback to the project team; review CRFs, data listings, and database to ensure all captured data follow the rules outlined by the protocol and data management plan
- Generate paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process; review responses to queries for appropriateness, resolve any discrepancies and modify the database accordingly
- Track CRFs as they are processed through the Data Management department
- Reconcile 3rd party data with CDMS data.
- Review and contribute to the development/update of department SOP’s and Working Guidelines
- Participate in project costing estimates and proposal review in the business development/change order process
- Participate in Proposal Defense and Capabilities presentations
- Interact with the Biometrics Project Manager on a continual basis throughout the course of the study
- Administer financial compensation for direct reports and propose adjustments (e.g., promotions, market adjustments, etc.) to departmental management
You’ll need this to be considered:
- Educated to Bachelor’s degree level or equivalent along 5 years data management experience including 3 years’ in clinical research, drug development or healthcare environment
- Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures; understanding and experience with up to date MS Windows Operating Systems and applications and at least one Database Management System (e.g., SAS, Oracle, Clintrials, Oracle Clinical, eDM, etc.)
- Proficiency with the development and review of Informed Consent Form templates
- Knowledge of ICH / GCP regulations
- Knowledge of web based communication tools for conferences
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
- Excellent team player, collaborative and able to build an effective team.
- Ability to multitask and work effectively in a fast-paced environment with changing priorities.
- Strong verbal and written communication and negotiation skills.
- Excellent organizational and time-management skills, able prioritize work to meet deadlines.
- Accountable, dependable and strong commitment.
- Customer service focused approach (both internally and externally).