Title: Lead Clinical Data Manager
Location: United States
This is a work from home position that can be worked remotely from anywhere in the United States
Senior and Principal levels are available depending on experience
The Lead Clinical Data Manager (Lead) will have experience in all required areas of a Lead Data Manager. The Lead is responsible for the data management project oversight resulting in quality and accuracy of the database for a clinical study. The Lead is the primary data management contact for the project and may also coordinate the work across multiple projects for a client program.
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.
- Exceed expectations and responsibilities of a Lead Data Manager
- Serve as primary point of contact for data management projects
- May serve as Biometrics lead for stand-alone studies including data management and biostatistics services
- Coordinate and ensure the accuracy and completeness of activities for data management assigned study team members
- Create material and present at study kick-off meetings, investigator meetings, client meetings, etc.
- Author and maintain all project start-up documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications
- Perform/provide oversight of user acceptance testing for assigned projects
- Create and maintain project timelines
- Prepare data transfer agreements & coordinate the receipt of data transfers
- Author all database lock documentation for assigned projects
- Prepare all data cleaning and data status documentation; including, but not limited to metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.
- Responsible for project budget oversight, revenue recognition, forecasting and billing/invoicing review/approval
- Serve as subject matter expert
- Provide training and mentoring for other Leads and Clinical Data Associates
- Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs
Standard Operating Procedures (SOPs)
- Strong understanding of departmental and company procedures; ability to guide others on procedures
- Participate in the development and revision of department SOPs
- May support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc
- Minimum of 5 years direct data management experience in pharmaceutical development or CRO environment
- Bachelor’s Degree preferred. Work experience may be substituted for degree
- Working knowledge of CDASH standards
- Excellent oral and written communication skills, organizational skills, and attention to detail are required
- Maintains a focus on key priorities and deliverables, staying resilient in the face of pressure.
- Uses challenges and new situations as an opportunity to learn and improve. Understands own “facts” and “stories” when in dialogue, and the impact leadership style can have on outcomes.
- Actively listens and learns from others, demonstrating patience and consideration for others’ concerns or frustrations. Asks questions for clarification and ensures message is understood. Takes time to digest what is heard before responding.
- Visible, approachable, and accessible. Encourages input and participation from colleagues to solve problems and innovate. Provides correct balance of direction and support to staff and colleagues according to each situation. Understands differences, anticipates areas of conflict and takes action.
- Evaluates and measures current processes. Works with a view of the future, prioritizing work in line with organizational objectives. Improves processes to maximize use of resources.
- Seeks opportunities to develop professional skills and knowledge and encourages team to do so. Supports and directs where appropriate, including recognizing achievements and providing constructive feedback and guidance. Cross-train others to broaden experience and develop potential.
- Translates major new directives into individual performance expectations. Explains and convinces others of the need for adaptation and change of policies, structures, and methods.
- Is comfortable facing issues with team members quickly and directly. Is willing to choose an approach that has not been tried before, or a leadership style that feels less comfortable if the situation demands it. Takes personal risks regularly and is not afraid to express bold opinions if the intention and motive is good.
- Consistently reflects the REAL values and inspires team to live and work by these values.