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A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

POSITION SUMMARY: The position is accountable for the successful execution of clinical activities assigned by the Functional Manager, Clinical Program Leader or Clinical Operations Head, within agreed timelines and budget, in alignment with all the applicable SOPs and regulatory requirements. This position leads the Study Management Team (SMT) and interfaces with the correspondent Clinical Teams, other Global Clinical Development Operations (GCDO) functions, Regional Trial Coordination/Site Management (TCSM) colleagues, Study Sites (if applicable), Central Business Operations, finance and the corresponding medical affairs team/Operating Company. Alignment of goals with organizational objectives as defined in the GCDO cascades,.

PRINCIPAL RESPONSIBILITIES: 

Considered the study owner and leader of the SMT. Main focus is on trial management supervision, planning and coordination. As part of the End to End Process (E2E) includes trial set-up, execution, analysis and reporting (includes trial closure) and post-study activities. Measures study progress against agreed upon timelines to milestones.

Ensure accurate budget management for assigned trials. This includes ensuring vendors and affiliate budgets are tracking according to plan. Updates are made to account for scope changes.

Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the SMT operates in a constant state of inspection-readiness. Ensure quality oversight of assigned trial utilizing the available tools. 

In coordination with the Clinical Program Leader, Study Responsible Scientist/Physician (SRS/SRP) and/or Clinical Leader, the GTM is responsible to ensure appropriate trial-specific training to the assigned TCSM or CRO staff as well as the site study staff. Work with TCSM (or CRO if applicable) staff in the set-up and coordination of Investigator Meetings, if applicable.

Ensure enrollment commitments meet the projected enrollment across the regions at the clinical trial level, monitors patient recruitment at the global level, and ensure timely and accurate documentation and communication of study progress and issue escalation.

Ensure deliverables are carried out according to the trial plan. Provides updates to all SMT and appropriate Clinical Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status according to trial plan.  

Strong interaction with the medical affairs team /Operating Company, other GCDO functions including Integrated Data Analyitcs and Reporting (IDAR), Pharmaceutical Development & Manufacturing Sciences (PDMS), Quantitative Sciences, Quality Management and Compliance, other research related functions (e.g., Reg Affairs) and external vendor groups, as applicable.

As assigned, ability to lead/contribute to cross-functional/organizational process streams.

PRINCIPAL RELATIONSHIPS: Describe the primary working relationships (internal & external) and primary interfaces.

Contacts inside the company:

Clinical Program Leaders, Clinical Operations Heads, Other Global Trial Managers, , R&D Country Directors, R&D Country Managers, Clinical Pharmacology Project Managers, Clinical Research Managers, Local trial Managers, Site Managers, Clinical trial Assistants, Pharmacokinetic Research Managers, Finance, Central Business Operations, IDAR, IDMs, Quality Management & Training group, Quality Assurance group, and different members of the Medical Affairs Team and the Clinical Team

Contacts outside the company: Multiple vendors, site study staff

EDUCATION AND EXPERIENCE REQUIREMENTS: 

BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)

Minimum of 8 years clinical trial experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.

Specific experience required of at least 7 year's duration within one of the following categories: Oncology Clinical Trial management or Large safety registries and Real world experience trials. 

Requires strong clinical research operational knowledge, excellent project planning/management and good communication skills, Experience managing or leading global or regional teams for complex trials in a virtual environment. Strong expertise in vendor management and systems. Excellent decision-making and strong financial management skills are essential to this position. 

Operates and executes with limited supervision. Experience mentoring/coaching others. Ability to support and participate in the hiring, training, development, and evaluation of staff on regular basis. Able to manage other associates if required.

Effective leadership skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required.

Warm Regards,

Sneha Shrivastava

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Tel: (732) 549 5307

Fax: (732) 549 5549

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70