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    Patel Consultants Corporation is an employee-based, customer-oriented Information Technology Services firm specializing in offering a wide range of IT Staffing Solutions to our growing customer base

Business Intelligence (32763)

The Senior Business Intelligence Analyst will be responsible for gathering and refining Business Intelligence requirements associated with the clients IVSM system. This individual should have experience analyzing business processes and corresponding information needs. The analyst will interview users in order establish reporting needs, define key performance indicators and their attributes, develop data requirements, document the BI project scope, and establish user acceptance criteria. He/she will also develop functional requirements documents and design BI reports.

The Analyst will:
• Assist the BI staff in the development and analysis of Business Requirements Documents
• Help identify, assess, and document potential data sources and flows, and analyze existing Enterprise Data Warehouse structures to determine relevance to the needs of the IVSM program
• Participate in generating high level solution concepts in consultation with BI Solutions Architects and Development teams
• Write Functional Requirements Documents, participate in document reviews with business users and Development teams
• Document user acceptance test plans
• Design reports for business users
• Work cooperatively with BI Solutions Architects and developers during the development life cycle to ensure that business requirements guide the development life cycle

Requirements and General Skills:
• Strong interpersonal skills
• Ability to interpret, analyze and solve business problems with information technology solutions
• Strong analytical and quantitative problem solving skills
• Excellent verbal and written communication skills
• Ability to advocate for the needs identified in conjunction with business partners
• Experience with a subscription based business highly desirable

Technical Skills:
• Knowledge of data warehouse architectures and processes
• Experience authoring technical documents such as business requirements, functional requirements, database design representations, data and systems flow diagrams
• Understanding of the features and capabilities of one more DBMS’s commonly used in data warehousing such as Oracle, Teradata, SQL Server
• Proven record of participating in the delivery of new and enhanced to business intelligence capabilities
• Expertise developing and applying relational and dimensional data models
• Understanding of ETL architectures and experience deploying ETL solutions in a data warehousing environment
• Ability to conceptualize and communicate reporting strategies that address a wide range of information needs
• Development experience with at least one business intelligence tool such as Microstrategy, Cognos, or Business Objects

Developer (32760)

Role / Responsibilities:

– Serve as lead technical resource to deliver mobile applications and solutions in collaboration with our business and technology partners.


Bachelor’s Degree required. Bachelor’s Degree in Computer Science is preferred.

• Skills / Experience:

– 4+ years experience developing iOS enterprise apps.
– Strong knowledge of iOS development, Xcode and Objective C.
– Experience with Android, Hybrid and HTML5 development.
– Demonstrated experience in Agile and waterfall development.
– Prior experience in management of offshore development teams.
– Strong knowledge of RESTful web services.
– Evaluate new technologies and work with the ECCM Solution Architect and Enterprise Architecture to develop new standards and document solutions.
– Work with Mobile deployment lead to onboard new and incremental mobile apps to our various internal and external app stores.
– Perform code reviews and ensure mobile development standards are enforced.
– Excellent written and verbal communication skills.
– Familiarity with submission of apps to the Apple and Google Play Stores.
– Experience with Cloud technologies a plus.

SAS (32759)

BA/BS or Higher in analytical disciplines.

SAS Experience in Pharmaceutical or equivalent: = 7 years. Oncology experience required.
Experience with applying censoring rules and deriving PFS, OS and other time to event variables needed.
Have good knowledge of statistical terminology, clinical data structure , clinical tests, medical terminology, regulatory standards and protocol designs.
Strong SAS programming / Macros development / SAS graphs skills.
Demonstrated proficiency in using SAS to produce derived analysis datasets and produce tables, figures, and listings (TFLs).
Provided programming support on NDAs, sNDAs, ISS, ISE and post-submission activities.
Ensure the consistency and adherence to standards within the project.
Convert, check and integrate multiple sources of incoming data into the creation of analysis datasets.
Perform ad hoc flexible and rapid programming to address questions that arise from planned analyses and results.
Performing programming validation to ensure the quality of analysis datasets and programming outputs.
Perform most job functions independently.
Able to address challenging requests from other functional areas.
Demonstrated ability to work in a team environment with clinical team members.
Good interpersonal, communication, writing and organizational skills.

Database Management (32757)

• Responsible for Lead Data Management activities (study start up to database lock) for Phase 1 Oncology studies
– Overseeing all CRO management including managing CRO deliverables and relationships at the study level
– Overseeing development and review on all CDM study-related documents (i.e. CRFs, Data Management Plan, CRF completion guidelines, etc.)
– Performing in-house monitoring of data entry into EDC Clinical database, data review and reconciliation of outstanding queries
– Assisting in the design of Data Documentation (paper prototype of CRF) in compliance with protocol assuring consistency, clarity, and simplicity
– Reviewing and contribute to the preparation of protocols from the DM perspective
– Responsible for receiving accurate data transfers and communicating with the CRO all discrepancies that are found
– Responsible for CDM process decisions with the CRO (i.e. moving study database into production environment, requesting/authorizing database modifications, database lock sign-off, etc.)
– Performing manual data review, generate data queries and issue the data queries to the site
– Updating the database per Data Clarification Forms, Data Resolution Forms, Self Evident Corrections, as well as Data Handling Conventions
– Reconcile coding and clinical operations data issues
– Generating weekly study data report
– Performing external data reconciliation (ECG)
– Performing Quality Control activities by reconciling quality control findings

Quality Assurance (32756)

1) Responsible for transitioning electronic Change Control Files from an existing module (GXP) to the new Global Change Management (GCM) module within eQRMS (EtQ based system). The transition process will be governed by a protocol and the incumbent would work within the instructions defined in the protocol to execute the transition process.

2) Support the Global QMS team in the management, processing and maintenance of the CAPA, Deviation, Product Quality Complaint and Change Management systems. This includes daily support activities such as:

– metric production (utilizing excel, powerpoint)
– report generation
– document management activities
– miscellaneous training related actions.

3) Support the implementation of new and/or enhancements to the existing electronic quality system platforms. Assists in the implementation of new practices/systems in keeping with constantly changing/emerging FDA/industry requirements.

BS in the Sciences or Pharmaceutical related field is preferred with 2-4 years relevant QA experience.
Alternatively, 2 years of higher education with 4 years relevant QA experience may be acceptable.
Good computer skills and working knowledge of common business software
Good knowledge of GMP requirements
Excellent organizational skills
Excellent problem-solving, verbal and written communication skills
Must have strong interpersonal and communication skills, be a team player
Ability to work accurately under tight deadlines.
Must be able to plan and manage multiple priorities.

Data Review (32749)

Responsibilities will include, but are not limited to:

1. Functional proficiencies:

• Reviews synopsis/protocol and attends Synopsis Review Committee (SRC) meetings
• Leads DM study start-up and maintenance activities
• CRF design/edit check specifications//external vendor specifications, CRF completion guidelines, (CCGs), coding, IVRS, etc.
• Leads development of site/investigator training materials and present at Investigator Meetings
• Leads Celgene team with User Acceptance Testing as applicable
• Leads SAE reconciliation
• Demonstrates ability to analyze data, share trends/observations with team members around results and relevant metrics
• Leads data review and query management
• Prepares the Data Management Plan and essential documentation
• Adheres to data standards and proper data validation processes
• Performs reconciliation of external data
• Leads database lock activities: inclusive of final SAE reconciliation/final data review, study decommission, etc.
• Lead/Participate in regular team meetings and provide input when appropriate
• Core study team member and primary contact for data management
• Provide input and assist in review/adherence to project timelines

2. CRO/vendor oversight:

• Provides oversight of vendor activities to ensure quality and timely deliverables
• Participates in CRO/external vendor selection
• Review Statement of Work (SOW)/contracts
• Provides CRO oversight of the data management functional activities and monitor progress and deliverables
• Ensures training on Celgene SOPs, if applicable

3. Additional Activities:

• Participates in writing/reviewing of functional SOPs/Working Procedures/Guidance Documents
• Leads/participates in department initiatives
• Ensures departmental companion groups (Programming, Coding, CDSI, etc.) are consulted appropriately on study decisions
• Trains Data Managers on Celgene standards and processes
• Liaise with cross-functional teams to provide data management deliverables to health agencies
• Participates in submission activities, if applicable

Knowledge/Competencies Required:

• Plans and executes own area of responsibilities through predefined standards and objectives
• Work is completed under minimal supervision; routine work may require little to no instruction
• Shows solid interpersonal skills and understanding of all project team functions to obtain necessary information from other project team members
• Working knowledge of EDC databases, preferably Medidata RAVE. Knowledge of J-Review or other reporting tool and basic understanding of SDTM and CDISC
• Strong written and oral communication skills
• Ability to work in a study team environment
• Intermediate knowledge of therapeutic area(s)
• Knowledge of FDA/ICH guidelines and industry standard practices regarding data management

Please note that the manager checked “yes” for travel and indicated 10%.

Administrative Assistant (32748)

Under the direction of supervisors, will be responsible for providing administrative support, as well as general clerical/secretarial support to the team. Ability to act as a team player, strong interpersonal skills, and willingness to multi-task and prioritize are critical requirements.

Responsibilities will include, but are not limited to, the following:
• Coordinate complex meetings with Senior Management across time zones (meeting logistics, teleconference/WebEx, room set up, agenda preparation, catering, etc.)
• Support approximately 10 stakeholders in general administrative support (arrange and schedule travel through the Concur travel system, compile and submit expense reports through the Concur expense system, manage daily calendars of managers using MS Outlook, registration for congresses/conferences).
• Support managers in HR process (coordinate recruitment process, schedule interviews, welcome and escort candidates as well as coordinate new hires with HR department and on-boarding process within the department.
• Provide administrative support to specific projects as needed requiring MS Excel, Word and PowerPoint.
• Provide back-up support to other assistants in the department as assigned.

Skills/Knowledge Required:
• Must have strong interpersonal skills, be a good network builder and be a team player with the ability to navigate the corporate environment.
• Displays can-do attitude with the ability to work in an environment where individual initiative and accountability to the team are required.
• Ability to balance urgent versus important priorities of multiple stakeholders as well as dealing with time pressures.
• Has great attention to detail and tenacious foll-up aligned with set processes.
• Must be able to work with limited day-to-day supervision.
• Profound understanding of Microsoft Office programs, including meeting coordination through Outlook and updating/developing documents in Excel, Word and Powerpoint.
• Excellent written and oral communication skills.

Quality Assurance (32747)

The primary responsibility of this position is the performance of Environmental Monitoring (EM) tasks along with associated Microbiology/bio-analytical testing and reporting for the clinical production of cell therapy products.

Responsibilities will include, but are not limited to, the following:

Environmental Monitoring of cellular therapy production areas:

•  Coordinate with Clinical Production staff for daily EM test schedule and activities.

•  Collection of EM samples (air, surface and personnel) from controlled laboratory areas. Aseptic gowning required for entry into controlled areas.

•  Processing, incubation and evaluation of environmental test samples and incubation chambers.

•  Organization and completion of EM documentation and entering of data into the EM software.

•  Perform trend analysis and lot release reporting of EM data. Analytical testing of cellular therapy products:

•  Perform in-process and final product analysis of clinical release which includes cell counts, viability analysis, and subculture.

•  Assist in analytical trouble shooting and investigations as needed.

•  Update and maintain analytical data in DQC database.

Other essential DQC tasks include:

Perform routine control and calibration of DQC instruments and equipment.
Participate in investigations as needed.
Monitor DQC inventory of reagents and supplies. Re-order as needed.
Other tasks as needed.

Skills/Knowledge Required:


•  B.S. degree (or equivalent) in Biochemistry, Biology or related discipline

•  1 year in a Quality Control laboratory or EM/Microbiology experience with experience working in Pharmaceutical Industry clean rooms.


•  2+ years in a Quality Control laboratory

•  Cell culture experience
• Experience with environmental monitoring and aseptic processing, general microbiology techniques and PCR technology.

Chemist (32746)

Manager provided the following job description:

Responsible for assisting in method development, conducting method validation, performing laboratory research and/or routine sample analysis under minimal guidance of a supervisor. Responsibilities will include, but are not limited to, the following:

Assist senior scientist to carry out methods development, optimization and validation for the analysis of drug substances, and finished products in accordance with cGMP regulations, established protocols, and applicable SOPs.

• Adhere to all pertaining compliance requirements.
• Contribute data for preparation of development, validation and technology transfer reports.
• Communicates results according to project timelines and works with colleagues and collaborators to
understand project needs.
• Performs troubleshooting within method guidance.
• Performs reference standard qualification/requalification tests.
• Performs release and stability testing in accordance with established methods, specifications and
protocols with limited supervision.
• Documents laboratory work that is detailed, timely and in compliance with GLP/GMP requirements.
• Other duties as assigned by his/her supervisor.

Skills/Knowledge Required:

Experience with HPLC, Dissolution, GC, FT-IR, KF etc. required.
Methods development experience for drug substances and drug products is required.
In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidances a MUST.
Familiar with USP and other compendia.
Working knowledge of Empower required.
MUST have working familiarity with cGMP practice.

Quality Assurance (32744)

Responsibilities will include, but are not limited to, the following:

1. Conducts QA review and approve all manufacturing/processing batch records and quality test records.

2. Ensures completeness and accuracy of all files received into Quality Assurance, according to SOP and to meet state and federal regulatory requirements.

3. Ensures readiness of records for regulatory inspection.

4. Completes and provides data for Continuous Quality Improvement for all batch and quality test records per SOP.

5. Revises existing standard operating procedures as needed for annual review and process changes.

6. Reviews proposed changes to existing Standard Operating Procedures as needed

7. Assists in the review and release of raw materials for use in the manufacturing/laboratory area

8. Coordinates back room activities for Regulatory Inspections.

9. Reviews, compiles and organizes data for trending.

10. Provides assistance to other QA staff members as needed.

11. Performs other QA duties as assigned.

Skills/Knowledge Required: Bachelors degree in a Life Science and/or equivalent work experience. Basic understanding of medical terminology and/or cell therapies. Detail oriented with high degree of focus. Able to interpret and follow set policies and procedures. Able to perform with minimal supervision and contribute in a team environment. Able to communicate results and issues effectively, both written and orally. Knowledgeable in Microsoft Office, with an emphasis in MS Word and Excel.

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