Manager, Clinical Data Management at BioClinica in Newark, California

Job Description:

This role is responsible for overseeing a specific therapeutic area and/or modality in order to provide accurate, timely, and consistent clinical data to client organizations and internal staff. Manages staff to define and direct the data management workflow for assigned projects, ensuring all necessary data quality control measures are in place. Serves as the data management expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables.

Primary Responsibilities

Ensures clinical trial databases meet project requirements by:

• Overseeing all data management deliverables for therapeutic area and/or modality


• Reviewing documentation and requirements for new projects and anticipating impact to data management and therapeutic area standards/processes


• Collaborating with appropriate project teams as needed to stay abreast of and changes that could affect data collection, cleaning and/or deliverables.


• Participating in sponsor meetings as requested.

Ensures data management deliverables are properly executed by:

• Understanding the requirements for study implementation, data collection and data analysis


• Collaborating with the project team to proactively identify and address issues and develop study-specific procedures as needed


• Evaluating and implementing the standard edit checks, recommending modifications where necessary


• Maintaining organized, complete, and up-to-date study documentation


• Keeping supervisor informed of the overall status of the teams

Ensures the accuracy and consistency of clinical databases by:

• Reviewing data and identifying errors/inconsistencies


• Collaborating with appropriate project team to prevent and resolve data issues


• Tracking outstanding issues and following-up until resolution


• Preparing and validating study metrics and ad hoc data listings as necessary

Performs supervisory functions by

• Communicating job expectations


• Planning, monitoring and appraising job results


• Coaching, counseling and disciplining staff


• Identifying and developing key staff to eventually assume greater responsibility and growth within the company


• Initiating, coordinating and enforcing systems, policies and procedures


• Approving direct reports time sheets, requests for time off and/or overtime


• Performing timely performance evaluations of direct reports


• Coordinating and conducting new hire interviews; facilitating hiring decision


• Training new hires on departmental processes and responsibilities


• Working with upper management in the continued development, coordination and implementation of support functions, processes, training program and evaluation of same

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by

• Adhering to department processes and standards


• Reading, understanding and adhering to applicable Standard Operating Procedures (SOPs)


• Assisting in establishing and enforcing departmental standards


• Participating in the review and updating of company and department SOPs related to department

Contributes to team effort by

• Working with internal staff to anticipate and resolve issues


• Exploring new opportunities to add value to the organization


• Helping others to achieve results


• Performing other duties as assigned

Maintains Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training


• Reviewing literature to stay current in the Data Management field

Qualifications:

Education:

• Bachelor's degree in Computer Science, Life Sciences or related field required

Experience:

• 7+ years experience in comparable position within the pharmaceutical, biotech or CRO industry


• Knowledge of clinical research, GCP, GCDMP, and related regulatory requirements desirable


• Knowledge of industry Clinical Data Management systems and programming languages desirable


• Understanding of software development cycle and 21 CFR Part 11 compliance requirements desirable


• Working knowledge of relational database organization and validation


• Familiarity with SAS desirable


• Experience working with office productivity tools including Word, Excel, PowerPoint and Access preferred


• Understanding of clinical trial terminology desirable


• Strong attention to detail and ability to take ownership of complex issues, ensuring resolution

Additional skill set:

• Ability to work independently in a group setting; ability to adjust to changing priorities


• Excellent attention to detail


• Strong interpersonal and communication skills, both verbal and written


• Strong documentation and organizational skills


• Ability to project and maintain a professional and positive attitude

Working conditions:

Travel: 0-15%

Lifting: 0-25lbs

Other: Computer work for long periods of time

EEO Statement

Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic

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