Overview

***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 clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. 

Responsibilities

• 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
• May support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc

Qualifications

• 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

Role Competencies:

• 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.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Group’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.