Associate Director, Clinical Data Management
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry one patient at a time. To help us achieve our goal, we are seeking a razor-sharp Associate Director, Clinical Data Management eager to make an impact within a mission-driven organization. The Associate Director, Clinical Data Management, directs the design, documentation, testing, implementation and archival of data from all clinical studies, in accordance with industry best practices and regulatory requirements. The Associate Director interacts with sponsors, project managers and all levels of internal staff in highly cross-functional project teams, acting as the lead in designing, implementing and documenting data collection for clinical studies.
DUTIES AND RESPONSIBILITIES
- Collaborate with other departments including Clinical Operations to provide early strategic input into protocol design focused on data management issues
- Manage vendors that perform any data management activities in accordance with contracted scope, costs and timelines
- Build effective working relationships with vendors
- Lead, direct, manage, develop, coach and evaluate direct reports, if assigned, and other employees in group in accordance with the Company's policies and plans
- Direct all phases of the company’s data management functions supporting clinical trials including Protocol Review, Database build, CRF design, Data Entry, Data Verification, Data Review, Query Management, Coding, SAE Reconciliation, SOP Development and Training for Data Management
- Keeps abreast of literature/advancements in data collection and repository systems, data structures and industry standards (e.g., CDISC), computing environments, tools and products
- Fosters open communications among cross-functional groups within the department as well as outside of the department to establish seamless and effective workflows
- Monitors project progress and ensures proper resource allocation for successful project deliverables against goals and timelines
- Conducts performance reviews, calibration sessions and feedback discussions for direct reports. Performs competency assessments across his/her team, and implements and monitors development plans with direct
- Oversees the development of training programs to ensure that all Clinical Data Management personnel appropriately interpret and follow procedures
- Oversees efficient allocation of Clinical Data Management resources to development projects through effective budgeting and reporting processes
- Develops recruitment and retention strategies in collaboration with the HR department
- Plans and budgets for resource allocation and infrastructure needs.
- Bachelor’s degree preferred, and a minimum 10 years supporting clinical studies, including at least 8 years in a clinical data management role in the CRO/biotech/pharmaceutical industry
- 5+ years of experience managing direct reports and overseeing vendors
- A strong understanding of US and EU (at a minimum) and other international pharmaceutical guidelines and regulations is required, particularly ICH, GCP and CDISC
- Excellent interpersonal, communication (oral and written), analytical and organizational skills
- Excellent team management skills: ability to lead, train and mentor team members at all levels
- Experience in building and guiding organizational Leverages each team member's unique background and perspective to achieve team goals while providing clear direction and accountabilities. Commitment to collaboration, within and across departments.
- Understands interpersonal and group dynamics and reacts in an effective and tactful manner and has a range of interpersonal skills and approaches with ability to select a best-fit
- Ability to motivate, influence and guide team members and direct reports; gains commitments from
- Proven ability to manage multiple projects and complex timelines in a team environment.
- Strong influencing and negotiation skills
- Ability to mobilize a team to be both productive and proactive
- Ability to communicate in English (both verbal and written)
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Enjoy daily healthy catered lunches, snacks and beverages, and top-notch equipment such as the latest Macbook Pro, 4k monitors, and adjustable standing desks. Submit your resume to apply!