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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

Software Developer (32645)

The IT Software Application Support Lead provides technical implementation and oversight to the Assay/Compound Request and Inventory Management System, and Biologics Registration System project teams in the Discovery Research, and has primary responsibility for delivery of technical solutions that meets or exceeds business requirements. This position will be based in San Diego, CA.

Duties & Responsibilities
• Provide technical leadership to ensure successful delivery.
• Ensure the technical solution will satisfy the requirements.
• Collaborate with project architect, infrastructure team, project manager, vendor as needed.
• Identify and communicate technical dependencies.
• Identify technical risks and mitigation activities
• Work with cross-functional teams to resolve technical issues
• Collaborate with the vendor on developing and implementing robust testing procedures.
• Provide technical input to the project schedule and plan
• Provide work estimates as needed

Skills
• Knowledge of Discovery Research applications, such as Compound Management and Biologics Registration
• Scientific Application support
• Experienced and skilled in working in a cross-functional team environment
• Excellent active listening, written and oral communication skills

Experience
• 3+ years experience in IT application delivery, support & management
• Biotech/pharmaceutical industry experience is desired, with particular focus on Discovery Research applications
• Experience with scientific application delivery and specifically Assay/Compound Request and Inventory Management system delivery is a plus
• Experience with Biologics registration System is a plus
• Strong knowledge of solution development life-cycle (SDLC) techniques and industry best practice

Education
• Minimal Bachelor degree in Computer Science, Software Engineering, Science, or related discipline

Posted in Computer Support, Developer, Information Systems, Information Technology, Jobs, Programmer/Analyst, Software Developer, Temporary/Contract Positions, Web Developer | Leave a comment

Management Consulting (32644)

Summary/Scope:

The [Senior] Study Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams.

Responsibilities involve a combination of execution and oversight—dependent on the sourcing model — to ensure deliverables and may include, but are not limited to, the following:
Financial Planning and Management:
•Development/management/reconciliation of overall study budget(s)
•Development/management of vendor scope of work (SOW) per contract, quality, and budget
•Review/approval of vendor invoices and management of accruals and SOW changes.
Project Management
•Oversight of study execution utilizing available performance metrics and quality indicators
•Oversight of clinical monitoring quality and adherence to established processes and plans
•Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
•Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
•Maintenance/updating of data as appropriate in project management tools including CTMS
•Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation
Study Planning and Conduct
•Facilitation of country and site feasibility/selection processes
•Operational input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
•Oversight of investigational product [IP]supply forecasting/management and study-level IP reconciliation [in collaboration with IMSC]
•Development of the subject recruitment/retention strategy and related initiatives
•Participation in clinical service provider (vendor) selection, specification development, and management/oversight
•Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance
•Development/coordination of study training for study team, investigational sites, and vendors
•Oversight of required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications
•Participation in Serious Adverse Event (SAE)reconciliation process
•Drive activities for efficient data cleaning and database closure.
•Lead close out activities for sites and vendors and studies.
•Able to handle multiple projects at one time.
Relationship Management
•Development/maintenance of collaborative relationships with:
o internal partners/stakeholders including Clinical Research, Project Management, CR&D Operations, and Affiliates external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers.
•Willing and able to act as a regional study manager supporting a lead.

Skills/Knowledge Required:

• Clinical trial project management skills.

• Financial budgeting and forecasting skills.

• Leadership / influence management skills.

• In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes.

• Ability to effectively lead a global cross-functional team in a matrix environment.

• Time management skills – ability to effectively multi-task and prioritize.

• Proven problem solving and decision making skills.

• Demonstrated success in using oral and written communication skills to influence, inform, or guide others

• Disease / therapeutic knowledge – At least 3 years experience with hematology/oncology or oncology. Early development oncology experience highly preferred (phase 1, First in Man).

• Solid computer skills – requirement of MS applications including (but not limited to) MS Project, Word, Excel

• Study Tools including electronic system skills – CTMS / EDC.
Able and willing to travel overnight if required, to sites or team meetings.

Education/Experience Required:
•BA / BS
•Degree in relevant discipline
•Minimum 6 years clinical study management experience with at least 2 years direct multinational study management experience
•Minimum of 2 years experience in oversight of CRO study execution
•At least 3 years experience with hematology/oncology or oncology.
Early development oncology experience highly preferred (phase 1).

Posted in Business Analyst, Computer Support, Information Systems, Information Technology, Jobs, Operations Manager, Project Manager, Temporary/Contract Positions | Leave a comment

Administrative Assistant (32639)

Bachelor’s Degree with 5 years of administrative experience in a business environment with increasing variety and complexity or equivalent

Responsible for general administrative support duties within a fast-paced, dynamic corporate environment. Confidentiality and the ability to handle confidential material is critical to the position. In addition, strong interpersonal and organizational skills and strength in working with others on a large team are also critical requirements.

Responsibilities will include, but are not limited to, the following:
1. Coordinate on-site and off-site meetings

•  Schedule meetings involving participants across multiple time zones and locations

•  Meeting logistics, teleconference/webex,/video, room set-up, catering, etc. Coordinate with hotel or other external venue representative

•  Work with other assistants to secure conference rooms and to modify calendars to accommodate meetings
2. Support team of ~10 people

•  Arrange and schedule domestic and international travel itineraries and related activities (flights, train tickets, hotels, car rentals, transfers, visa requisitions) through Celgene’s travel systems

•  Compile and submit expense reports in accordance with Celgene Travel Policy through expense reporting and filing system

•  Manage daily calendars through MS Outlook

•  Registration for congresses/conferences
3. Support managers in HR processes

•  Coordinate recruitment processes, schedule interviews and welcome candidates

•  Coordinate arrival of new hires, related activities with HR department, induction program
4. Provide administrative support on specific projects requiring MS Excel, Word, and Power Point skills

Posted in Administrative Assistant, Applications, Computer Support, Information Systems, Information Technology, Jobs, Project Coordinator, Technical Support, Temporary/Contract Positions | Leave a comment

Clinical (32638)

BA/BS or Higher in analytical disciplines.

SAS Experience in Pharmaceutical or equivalent: = 5 years. Oncology experience is a must.
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.
Creating Data Definition Tables (DDT) and convert TFLs to the required format for eSubmission.
Perform most job functions independently.
Provide flexible and rapid response to programming requests.
Work on project assignment under the direction and lead of programmer / statisticians.
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.

Posted in Clinical Data Manager, Computer Support, Information Systems, Information Technology, Jobs, Programmer/Analyst, Scientist, Technical Support, Temporary/Contract Positions | Leave a comment

Administrative Assistant (32637)

Candidate will be responsible for providing administrative support to the Directors in the Corporate Communications department. Successful candidate will possess a polished, professional demeanor and have strong oral and written communication skills. Candidate must be able to multi-task and work independently while managing multiple priorities in a busy, fast-paced corporate environment. The ideal candidate would be a detail oriented professional who works with a sense of urgency to accomplish tasks with appropriate follow up.

**conducting a software skills test would speak volumes as to the technical skills of the candidates. We need someone to come in with very recent experience using our systems to eliminate the retraining of basic skills such as expense report processing, etc. Important platforms to have mastery of would include Microsoft Office Suite, Concur as well as Oracle Iprocurement . Also requested would be writing samples, as having solid business writing skills is necessary working in a Corporate Communications role as we frequently interact with the C-Suite.

Responsibilities will include, but are not limited to the following:
• Heavy calendar management and scheduling of executive meetings
• Coordination of internal communication production schedule – active liaison with stakeholders
• Manage legal contract process for various vendors
• Create purchase orders, process departmental invoices
• Prepare and process expense reports and travel arrangement
• Process conference registrations
• Facilitate conference calls and webex
• Proof various materials for production
• Back up admin support for VP’s administrative assistant during absences

Skills/Knowledge Required:
• Strong grammar, business writing and proof-reading skills are necessary*
• Microsoft Outlook:** advanced skills, calendar and meeting scheduler
• Oracle Iproc:** advanced skills in requisitions, purchase orders and contract processing
• Concur:** expense reporting
• Ability to work proactively and independently, as well as part of a team as some projects require collaboration
• Excellent organizational, time management and problem solving skills
• Able to handle confidential materials successfully
• College graduate strongly preferred

Posted in Administrative Assistant, Applications, Helpdesk, Information Technology, Jobs, Project Coordinator, Temporary/Contract Positions | Leave a comment

Safety (32636)

Qualifications: BS, preferably in a health related setting (or equivalent combination of education and experience).

Experience: Minimum 3 years of related experience in clinical records/data processing/medical transcription setting.

Knowledge:
-Familiar with database usage
-Word processing experience
-Document management and archiving practices

Coordinate the receipt of AE case reports, specifically:
Retrieve case
Initial and date stamp source document
Log receipt of self-evident follow-up as communication in IRT
Copy and send source docs to Clinical Ops if clinical SAE
Check initial source doc completeness
Initiate follow-up if needed & log communication in IRT
Perform duplicate search
Identify exact duplicate source doc and file
Perform initial data entry in IRT
Determine if AE / Non-AE
Identify Non-AE follow-up needs and generate letters and attachments
Update Non-AE items
Identify PQ complaint and notify Quality
Attach any provided electronic documents to case in IRT
Execute exchange of information (e.g. contractual partners, Alkeran)

Execute pre-defined follow-up measures and due diligence, specifically:
Pull list of follow-ups to be sent by day in the IRT Communications module
Send out follow-up letters
Apply due diligent measures
Update follow-up communication in IRT
Print, assemble and send follow-up letters/queries and attachments for all cases
Generate daily listing of cases that need subsequent follow-up and send subsequent follow-up letters/queries to ensure due diligence is performed
Review & identify follow-up outside of due diligence measures
Initiate reminder of further follow-up as needed
Elevate outstanding follow-up (clinical trial case)
Log follow-up measures as communication in Communications module

Competencies:
-Attention to detail
-Time Management
-Strong team work
-Possess good analytical skills
-Strong communication skills demonstrated by the ability to ask questions, express opinions and/or offer suggestions for process improvement.
-Strong professional interpersonal skills demonstrated by daily interactions with co-workers.

Posted in Computer Support, Information Systems, Information Technology, IT Security, Jobs, Safety Data Systems, Temporary/Contract Positions | Leave a comment

Operations (32634)

POSITION SCOPE
The Batch Review Coordinator is responsible for the receipt of completed batch records and associated batch record documentation, such as testing data, and the audit required of all documentation prior to release. This includes the appropriate filing and scanning of the completed batch records, as well as the supporting documentation required during the review process of the batch records and testing documentation. Upon completion of the review documentation, generation of the Certificate of Analysis is required per the applicable specification, as well as any other required documentation (checklist, C of C’s, etc.) The Batch Review Coordinator is also responsible for the management and verification of the required manufacturing and testing data required for trending purposes.

ESSENTIAL FUNCTIONS

1. Able to perform technical review functions for pharmaceutical/regulatory manufacturing and testing documentation. Identification of key issues, errors, discrepancies and Good Documentation Practices.
2. Reviews and request revisions of Standard operating Procedures, in support of the maintenance of batch records filing systems and the associated review processes.
3. Receives/Reconciles/Organizes all batch record and product testing documentation for filing.
4. Lead the collection and compilation of required MQR/APQR data and implement other documentation/data management systems as required.
5. Compile all trending data for MQR, inspection requests and FDA audit requests.
6. Responsible for the Master Batch Record control and maintenance.
7. General knowledge of discrepancy reporting (Deviations, OOS, OOT).
8. Required to supply miscellaneous reports, batch record copies and associated documentation for support groups.
9. Maintain electronic filing system for batch documentation, archive documentation as required.
10. Work with CSP in providing batch record corrections, development of path forwards in addressing recurring issues and obtaining overall understanding of all manufacturing and testing processes. Resolve documentation discrepancies prior to pre-disposition review.
11. Coordination of documentation requests during audits and regulatory inspections.
12. Assist management in accomplishing global projects and initiatives as well as developing systems for the overall assurance of accurate and appropriate processing of all documentation.
13. Provide accurate tracking of received documentation and timely completion of all required review tasks.
14. Performs other duties and responsibilities as delegated by Sr. Manager, Compliance.

EDUCATION/EXPERIENCE REQUIREMENTS

• The position of Coordinator, Quality Operations requires a HS diploma or equivalent. Equivalent combination of education and applicable experience in a FDA/USP/EU regulated environment acceptable (Associates degree or BS degree preferred)

REQUIRED COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES

• Requires proficiency in basic Microsoft Word, Excel, Powerpoint, Lync and Outlook. Familiarity with Adobe pdfs and use of SharePoint.
• Requires the ability to multi-task, great organizational and time management skills and able to work as a part of a team.
• Strong written and verbal communication skills
• Directly contributes to the team performance based on individual performance as well as team member contribution.
• Consults management on job functions and decisions; tasks are given in broader terms and reviewed for accuracy; reports problems and solicits direction.
• Begins to recognize basic Quality issues and report and works with management and/or CSP to resolve.
• Follows established procedures and performs work as assigned.
• Follows directions and communicates effectively with peers, team and supervisor and builds internal relationships within function, including CSP.
• Contributes to team goals as directed.
• Basic GMP and Quality knowledge.
• Able to properly communicate e-mails and routine business matters with management with a high level of accuracy.

Posted in Compliance Specialist, Computer Support, Information Systems, Information Technology, Jobs, Operations Manager, Quality Assurance, Temporary/Contract Positions | Leave a comment

Compliance (32633)

We have an opportunity with our client in Horsham, PA area. They are in need of a Compliance Investigator.

The Compliance Investigator is responsible for the investigation of Individual Case Safety Reports and Aggregate Reports submitted late to Health Authorities. Health Authorities in scope for investigations are defined by departmental SOPs. This position is also responsible for investigation of other key compliance issues (as defined by Senior Leadership) related to work produced within GMS and GMO; or produced by a vendor on behalf of these organizations. The Compliance Investigator is also responsible for review and approval of single case deviation memos and aggregate report deviation memos ensuring completion within specified timelines and that documentation of immediate cause and corrections / corrective actions are complete and robust.
The Compliance Investigator will be responsible for one or more of the following areas: preparation of monthly compliance metrics and immediate cause summaries, analysis of compliance data, including identification, evaluation, tracking and trending of global compliance issues, assessing effectiveness of corrective actions, ensuring that relevant compliance information is provided to senior management and the QPPV Office, and coordination of regulatory compliance tracking for specific products, supporting compliance of business partners and driving projects related to compliance processes. Additionally, the Compliance Investigator will provide input and consultation to corrective / preventive actions and effectiveness measures for CAPAs related to late ICSR or Aggregate Report submissions.

Posted in Compliance Specialist, Computer Support, Information Systems, Information Technology, Jobs, Quality Assurance, Temporary/Contract Positions | Leave a comment

Pharmacovigilance (32632)

Our client is in need of a Pharmacovigilance Scientists. The term of the assignment is approximately 12 months and will be based near Horsham, PA. Candidates must have Drug Safety Aggregate Reports experience.

Responsibilities and skills include:
• Perform aggregate safety analysis and case level review
• Author, contribute, and coordinate the preparation of core safety deliverables (Aggregate Reports, Adhoc reports).
• Ensure commitments (e.g., PVAs, assessment reports) are met
• Work closely with management to proactively support TA-related business
• Provide SMT support to enable proactive safety management
• Be responsible for product accountability by maintaining product intelligence (i.e., creating agendas and documenting decisions, milestones, action items in minutes)
• Deliver innovative solutions for aggregate safety strategy and analyses
• Bachelor’s Degree in Health or Biomedical Science or Advanced Degree Preferred in Health or Biomedical Science (PharmD/MD/PhD.) or Clinical/Medical writing or PV experience required
• Excellent English verbal and written communication skills
• Project management experience

Posted in Biologist, Biostatistician, Chemist, Computer Support, Information Systems, Information Technology, Jobs, Scientist, Temporary/Contract Positions | Leave a comment

Sales – IT Staffing

Patel Consultants Corporation is a highly successful Information Technology Consulting Services firm that has been providing staff augmentation services to major Corporations and mid-sized firms since 1973. Our corporate office, located in Union, NJ, allows us access to the hub of IT staffing requirements in the Northeast Corridor.
We are currently seeking a Salesperson with a proven track record in IT Staffing services that can assist us in increasing our customer base.

This successful candidate should possess some or all of the following:

– Strong interpersonal skills;

– 5 + years of experience selling IT Staffing Services;

– Experience forming new client relationships and maintaining existing ones

– Specific industry knowledge is not critical but familiarity with the Life Sciences Sector is a plus

We offer an excellent salary/commission/benefits plan commensurate with proven track record.

Please e-mail resume to resumes@patelcorp.com or fax 908-964-3176 attn Nick Patel.

Patel Consultants Corporation 1525 Morris Ave. Union, NJ 07083

Posted in Direct Hire Positions, Full Time Positions, Human Resources, Information Systems, Information Technology, Jobs, Recruiter, Sales, Technical Recruiter | Leave a comment
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