Job Description

Overview:

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

 

The Lead Data Manager 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.

Responsibilities:

Responsibilities

• Serve as primary point of contact for data management projects
• Coordinate and ensure the accuracy and completeness of activities for data management assigned study team members
• 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 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.

Standard Operating Procedures (SOPs)

• Strong understanding of departmental and company procedures; ability to guide others on procedures

Qualifications:

• Minimum of 2 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

• Development of more advanced skills and knowledge relevant to the function. Able to perform routine assignments with little supervision and participate in more complex assignments.
• Maintains continuous, open and consistent communication with customers. Listen and ask questions to understand customer's viewpoints.
• Establishes effective relationships with customers to understand and meet their needs. Ensures customer service standards are met.
• Questions currently accepted ways of doing things. Generates alternatives before settling on a solution.
• Manages own time and workload effectively. Supports team through achieving project deliverables and objectives.

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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