Clinical Data Manager

 

Clinical Data Manager (CDM) –

Full-time The Clinical Data Manager CDM leads and monitors the collection, processing, data entry, and quality control of study data.

They are responsible for effectively managing timelines, quality and delivery of data for assigned projects that are in support of clinical trials research.

She/he develops and maintains successful working relationships with their team to ensure and maintain data integrity and quality.

Applying GCP and GCDMP principles, the CDM manages the protocol/study specific tasks including coordinating clinical and laboratory database deliverables, working with collaborators on data content requirements, leading data quality and closeout activities throughout the data management lifecycle.

The position of the CDM is also expected to manage basic science questions/queries, clinical development tasks associated to the management of trial data, and internal projects.

The CDM adheres to Standard Operating Procedures SOPs , work practices, applicable clinical trial regulations, and study confidentiality requirements and functions with limited supervision in operational and technical matters within defined procedures and practices.

 

Your responsibilities in this position will include:

Manage study/project implementation including but not limited to leading our team members through CRF, lab, and other data collection processes, reporting and analysis requirements, study/project documentation and training

Effectively manage assigned protocol/study, establish timelines and milestones in conjunction with department management, and monitor and communicate ongoing status and progress

Ensure rapid resolution of issues/conflicts using appropriate internal and/or external resources, tracking and managing the escalation of issues to ensure appropriate resolution in a timely manner

Participate in development of a protocol/study from draft status to optimize the collection of accurate and high-quality data

Work with project sponsors, stakeholders and cross-functional team members to define project requirements, scope, risks, organization, and approach

Act as subject matter expert for data management issues between study team staff and external domestic and international research sites for assigned studies

Assist in the development of Case Report Forms CRF s for assigned studies

Collaborate in the design of the protocol/study specific database for assigned studies

Assist in the maintenance of the study database including routine revisions or additions to include the design and/or modification of routine and existing study database edit check programs for assigned studies

Perform User Acceptance Testing (UAT) for assigned studies

Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures

Generate QC reports for site review and correction as well as a variety of other reports required • Evaluate study data for protocol compliance

Maintain the documentation of the study database and other related data management programs and/or applications

Ensure that company meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP)

Complete studies/projects ensuring completeness, documentation and storage

Assist in the development of procedures and best practices as warranted

Assist in the development and maintenance of standardization tools and training materials as requested

What education, experience, and knowledge do you need?

Requires a university degree, BA/BS, ideally with a degree in a Life Science, Library Sciences or Computer Science • 3+ years of experience as a CDM in a pharmaceutical or CRO setting

Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle) is preferred

Proficiency in the development and use of commercial EDC products, preferably Medidata RAVE/Balance/CTMS

Proficiency in MS Office Suite (including Word, Excel, PowerPoint)

Knowledge of FDA regulations and ICH, GCP and GCDMP guidelines

Excellent verbal and written communication skills

Excellent interpersonal skills

Excellent project management and organizational skills in a clinical trials setting Behavioral Competencies

Required:

Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates as well as vendors

Demonstrated ability to develop and present varied and unique ideas

Ability to display strong analytical and problem-solving skills

Detail orientation required Other Requirements:

Possible travel, including overnight and international travel based on organizational and/or protocol specific need

Physical Demands Required:

May encounter prolonged periods of sitting

May frequently be performing repetitive movements such as typing on a keypad or using a mouse

May climb, bend, reach, push, pull, balance, stoop, kneel, or crouch

On occasion, may lift and/or move up to 20 pounds

Our client is a commercial stage bio-pharmaceutical company with a variety of disease area therapeutics, also with some phase 2 and 3 clinical stage development programs.

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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