Team Lead, Clinical Supply Chain Systems Administration

BioClinica, Inc New London, CT
Primary Responsibilities

Responsible for oversight of team tasks, performance and morale in addition to providing system, lifecycle and reporting support for client's clinical supply chain. Employees in this role may perform facets, and not the full breadth, of system maintenance and reporting responsibilities defined below.

Provide leadership, structure and vision to meet established operational and financial goals and objectives by:

* Communicating job expectations

* Planning, monitoring and appraising job results

* Evaluating workload of staff to ensure projects are on time; affecting change when necessary

* Assigning tasks amongst team, considering skill set and workload

* Researching and resolving identified personnel/training issues

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

* Leading the hiring and termination of team members

Maintains strong client partnership by:

* Building and maintaining partnerships with customers at all levels

* Identifying and reporting on key team performance metrics

* Engaging with client oversight representative to remain informed of priorities and future objectives, proactively preparing team

* Consistently monitoring client satisfaction level, resolving issues and escalating concerns to manager as appropriate

Provide overall support of supply chain applications and finished clinical trial supplies by:

* Providing maintenance and administrative support of multiple supply chain specific applications

* Providing user support and guidance to navigate and utilize supply chain systems

* Addressing account maintenance escalations via a ticketing system

* Interfacing with internal/external customers, IT staff and vendors to troubleshoot, resolve or escalate identified issues

* Assessing content of raw data sets and comparing with source systems to identify data integrity issues

* Reviewing dataset contents and applying updates to non-validated source supply chain applications

* Submitting system performance related feedback to client system owner for consideration

* Providing content of artifacts to address system issues and/or performance to client system owners

Supporting application system releases

* Preparing for, executing and/or post reviewing; User Acceptance Tests, Production Qualification Tests, Operation Qualification Tests and Regression Tests; documenting results and escalating as needed

* Performing production release support activities for applicable applications, following the completion of client defined training

Messaging/interface troubleshooting

* Supporting data set assessment via designated tool, in partnership with client Oversight Manager

* Providing secondary support to Clinical Supply Operations Organization, as needed

Participating on project teams

* Representing team in project specific meetings

* Liaising with client Oversight to select Bioclinica project team members with relevant subject matter knowledge and experience to contribute to team effort

* Assisting client Oversight with project schedule creation

* Collaborating with client Oversight to assemble requirements, representing the needs of the business

* Contributing job function knowledge and experience to support the execution and attainment of project goals

* Facilitating goal setting and prioritization of work to successfully deliver project within defined schedule

* Consulting with client Oversight to evaluate impact of project scope increase/decrease on available team resources and existing deliverables

Ad-Hoc Reporting

* Collaborating with requestor to define initial requirements

* Providing sample data set to refine and confirm requirements

* Leveraging existing queries, adding tables and corresponding joins to meet customer requirement

* Creating custom reports, when unable to leverage existing queries

* Utilizing peers to review and verify report output against the source system application

* Escalating, following team process, to the client OSM or to the appropriate Business Technology personnel to ensure the quality of the data and accuracy of the deliverable

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by:

* Reading, understanding and adhering to job function Standard Operating Procedures ("SOP")

* Contributing experience, as applicable, to update job function Standard Operating Procedures ("SOPs")

Engages in Internal and External Audits by:

* Preparing for and Participating in internal/external audits

* Collaborating with Client to create audit response documentation

* Contributing to and implementing corrective actions in response to audit findings

Supports Quality Investigations and Remediation by:

* Demonstrating ownership of Quality Events and Investigations, in collaboration with Client

* Proposing, implementing, and reinforcing corrective/preventative actions in response to Quality Events and Investigations

* Mentoring team on quality assurance processes and tools

* Maintaining adherence to Client QA procedures

Exhibits and Reinforces Professional Conduct by:

* Defining, Communicating and Modeling professional and collaborative business conduct for junior staff

* Exhibiting solution focused and collaborative behavior

* Maintaining respectful and constructive dialogue with colleagues and clients

* Responding to colleagues and clients in a timely manner

Contributes to Team Training and Mentoring Support by:

* Contributing to team training plans and overall team knowledge improvement

* Identifying gaps in existing training materials and processes, providing recommendations to remedy

* Creating, implementing and presenting cross training materials &/or tools for both internal and external teams

* Providing oversight to new hires during management of first studies and/or re-works on active studies

Maintains Technical and Industry Knowledge by:

* Attending and participating in applicable company sponsored and client-required application training

* Self-directed learning of applicable tools, processes, and industry standards

* Attending product demos and product specific release meetings

Qualifications:

Education:

Bachelor's degree preferred

5+ years of experience may be considered in lieu of a degree

Experience:

5+ years of experience managing clinical supply chain systems

Demonstrated ability to perform tasks aligned with the role will be considered in lieu of years of tenure

Minimum of three (3) years of experience with significant responsibilities for customer relations and personnel management

Proven ability to effectively lead a diverse team throughout system maintenance and release initiatives

Excellent interpersonal skills and ability to manage client expectations required

Experience with SQL, Business Objects, Excel process using macros/advanced formulas, Spotfire and/or other data visualization tools

Working knowledge of FDA and international regulatory standards related to product realization/safety

Understanding of regulatory requirements related to Clinical Study operations (including GCP, GMP, and GDP) preferred

Additional skill set:

Strong organizational and leadership skills

Able to coach and motivate individuals

Able to maintain professional and positive attitude

Conduct reflects integrity, honesty, and responsibility for decisions and behavior

Able to handle difficult and stressful situations with professionalism, initiative, logic and good judgment

Strong interpersonal and communication skills, both verbal and written

Able to apply procedures across an extensive range of scenarios which will require strong problem solving and investigation skills

Excellent attention to detail and orientation toward meticulous work

Demonstrated ability to manage time and multiple tasks, effectively prioritize responsibilities and successfully meet deadlines

SharePoint knowledge and general maintenance preferred

Proficient with computer software including MS Word, Excel, and PowerPoint

Working conditions:

Travel: 20% - 30%

Lifting: 0-15lbs

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.

This position 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.