Manager, Validation Services

Job Description

Primary ResponsibilitiesActively participates in the testing of new BioClinica products by:

• Developing test cases and study data
• Conducting testing for general testing of BioClinica products
• Conducting testing for eClinical development tools
• Reporting testing and review anomalies, as appropriate, to the department head

Actively participates in post-production product release testing by:

• Developing test cases
• Conducting regression and bug fix testing for BioClinica products
• Conducting regression and bug fix testing for eClinical development tools
• Reporting testing and review anomalies, as appropriate, to the department head

Actively participates in peripheral software testing by:

• Developing system test use cases and study data
• Conducting system testing of the software
• Reporting testing and review anomalies, as appropriate, to the department head

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 software development processes and responsibilities
• Review team s performance on a quarterly basis.

Contributes to overall company communication, cooperation and efficiencies by

• Communicating team updates to appropriate personnel throughout company
• Working with the BioClinica s management team to streamline processes
• Always considering the impact of validation s processes, productivity and communication on other departments and the company as a whole when implementing and managing processes
• Frequently interacting with other departmental supervisors and managers to keep abreast of their respective environments (e.g. new ideas, process changes, staffing concerns, etc.)

Serves as liaison between validation and other departments by

• Proactively cultivating and maintaining effective working relationship with all functional groups
• Representing software developers in meetings
• Assisting in analyzing processes and process changes for greater efficiency

Secondary ResponsibilitiesContributes to team effort by

• Exploring new opportunities to add value to organization and departmental processes
• Helping others to accomplish results

• Performing other duties as assigned

Maintains Professional and Technical Knowledge by

• Attending and participating in applicable company sponsored training
• Attending educational workshops and reviewing professional publications
• Benchmarking state-of-the-art practices
• Participating in professional societies
• Keeping informed of changes in the regulatory environment and/or regulatory requirements

Qualifications: Education:

• Bachelor s degree required, preferably in computer sciences, or equivalent and relevant work experience in a software product development environment.

Experience:

• 8 years working in a software product development environment, preferably developing software or designing testing scripts and suites such as Installation Qualifications, Operational Qualifications, Performance Qualifications
• Experience with regression testing, defect reporting, XML, and SQL required
• Experience with JBOSS and SQL server strongly preferred
• Prior testing experience with pharmaceutical related software required
• 5 years experience working with clinical trials and/or within pharmaceutical environment required
• Previous management experience in a clinical imaging environment and/or clinical trials experience within a CRO or pharmaceutical research organization preferred

Additional skill set:

• Strong interpersonal and communication skills, both verbal and written
• Unwavering commitment to service and product excellence
• Strong documentation and organizational skills
• Goal oriented
• Ability to make sound judgments
• Superior problem-solving skills
• Ability to manage multiple tasks effectively & efficiently

Working conditions:Travel: 0-10%Lifting: 0-50lbsOther: Computer work for long periods of timeEEO StatementBioclinica 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.Collaboration, Continuous Learning, Critical Thinking, Operational Excellence, Organizational Awareness, Results Orientation, Service Orientation, Team Development,

Keyskills :
software product developmentuse casesnew hiressql servertest casessystem testingproblem solvingclinical trialspost productionsoftware testingteam developmentdefect reporting