Director, Tech Product Development at BioClinica in Princeton, New Jersey

Posted in Other 4 days ago.

Type: Full Time

Job Description:


Manages the company s development and unit testing process to ensure the delivery of Bioclinica Software products to customers in a timely, accurate and complete manner by:

* Lead in the design of new software, modifications or enhancements

* Developing new software applications following the design specifications and Standard Operating Procedures (SOPs)

* Gathering and evaluate user requirements

* Updating existing software applications to meet changes and enhancements in specifications

* Evaluating feature requests in order to update existing software applications to meet changes and enhancements in specifications

* Identifying risk in feature enhancements in order to determine development order

* Providing estimates for development work and working with management to schedule and staff assignments

* Evaluating and monitoring progress and workload of staff to ensure projects are on time, affecting change when necessary

* Keeping department head advised of current issues

Ensure all software documentation is accurate, up to date, and complies with company and regulatory requirements by:

* Drafting design level and functional requirements

* Reviewing code-review and unit test documentation

* Review Validation Documentation

Provides technical support and guidance to all internal and external application users by:

* Answering questions regarding application design and functionality

* Assisting Application Support Personnel in troubleshooting (level III)

* Supporting and ensuring application functionality including database integrity, data loading, data quality assurance and data export

* Assisting Validation Analysts with Quality Assurance reviews and sign-off.

Performs supervisory functions by:

* Communicating job expectations

* Planning, monitoring and appraising job results

* Coaching, counseling and disciplining staff

* 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 company processes and responsibilities

Contributes to overall company communication, cooperation and efficiencies by:

* Providing Sales support during potential customer meetings to explain the study design and development process

* Developing demonstration databases for sales and marketing purposes to aid in potential customer understanding as to the structure of clinical databases

* Communicating departmental updates to appropriate personnel throughout company

* Working with the senior management team to streamline processes

* Considering the impact of processes, productivity and communication on other departments and the company when implementing and managing processes

* Frequently interacting with other departmental supervisors and managers to keep abreast of their respective environments (i.e. new ideas, process changes, staffing concerns, etc.)

Maintains Quality Service and Departmental Standards by:

* Reading, understanding and adhering to organizational SOPs

* Assisting in establishing and enforcing departmental standards including defining, documenting and implementing applications development standards as needed

* Participating in the modification of company SOPs related to eClinical Solutions


Contributes to team effort by

* Exploring new opportunities to add value to organization and departmental processes

* Helping others to achieve results

* Performing other duties as assigned

Maintains Technical and Industry Knowledge by

* Attending and participating in applicable company-sponsored training

* Maintaining a strong understanding of software development trends and technology

* Maintaining a strong understanding of the regulatory requirements applicable to applications development in clinical trials

* Contract Resource Management

* Management oversight contractors assigned to project

* Management oversight of fixed price projects, ensuring system requirements and architecture is followed

* Release project coordination between contractor lead projects and in-house developed projects.



* Bachelor s degree in computer science or related field required

* Coursework in software development and major programming languages preferred

* Microsoft Certified Solutions Developer or Sun Certified Java Developer desired

* Scrum Certifications desired


* 5+ years experience in software development using a commercial programming language such as Java, C++, or .Net

* Knowledge of web security, web UI design, and XML serialization

* Demonstrated ability in data and service layer design and implementation

* Experience leading a Test and/or Validation team

* Proven ability to manage the full life cycle of a development program

* 3+ years experience working with clinical trials and/or within pharmaceutical environment preferred

* Working knowledge of the drug development process including knowledge of FDA requirements for GxPs and 21 CFR Part 11

* Proven problem solving abilities

* Experience in SAS programming a definite plus

Additional skill set:

* Ability to drive and navigate projects to completion

* Ability to work in group setting and independently; ability to adjust to changing priorities

* Excellent attention to detail and orientation toward meticulous work

* Strong interpersonal and communication skills, both verbal and written

* Strong organizational and leadership skills

* Ability to project and maintain a professional and positive attitude


Travel: 0-10%

Lifting: 0-20 lbs.

Other: Computer work for long periods of time

This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs..

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.