Overview

***This is a work from home position that can be worked remotely from anywhere in the United States***

The Manager, Data Management is responsible for managing all aspects of data management activities and assigned direct reports to ensure all time frames and targets are met. The Manager, Data Management may serve as portfolio level oversight or as Biometrics Project Manager for data management and biostatistics stand-alone programs.

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.

Responsibilities

• Onboarding of new employees; including training on data management procedures and systems
• Mentor, monitor and supervise direct reports (including monitoring time reporting and training requirements)
• Responsible for the hiring, promotion, transfer and release of staff
• Conduct performance reviews and assist with goal setting of direct reports
• Provide input on resource planning and assignments
• Project budget oversight; including revenue recognition, forecasting, billing, invoicing and change orders
• Identify and manage project risks
• Participate in data management candidate interviews
• Implement and maintain performance metrics
• May facilitate department meetings
• Coordinate and ensure the accuracy and completeness of activities for assigned oversight studies
• Create material and present at study kick-off meetings, investigator meetings, client meetings, etc.
• Review and ensure the quality of data management documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check Specifications
• Strong understanding of departmental and company procedures; ability to guide others on procedures
• Participate in the development and revision of department SOPs
• Support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
• Perform other duties as requested by management

Qualifications

• Minimum of 6 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
• The ideal candidate will have 2 years of management/leadership experience, but is not required
• Good knowledge of medical terminology and conduct and analysis of clinical trials
• Knowledge of relevant industry data standards (e.g. CDISC, CDASH)
• Excellent oral and written communication skills, organizational skills, and attention to detail are required

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.

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