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Clinical Data Analyst ll
Ref No.: 18-00191
Location: Raritan, New Jersey
Start Date / End Date: 02/01/2018 to 12/31/2018
POSITION SUMMARY: The Clinical Registry is responsible for posting accurate, validated and consistent information about our trials and their results on about 40 registries globally. These registries include regional and local country specific registires. In some registries, CR has direct responsibilities while in others, oversight and support is provided. The CR is the center of expertise for disclosure requirements and ensures data quality and compliance requirements for all registries are met. The CR is based in BRQC Client, but supports all pharma, consumer and medical devices operating companies that have studies with disclosure requirements. We work closely together will clinical and medical teams, clinical development operations, regulatory affairs, biostats, programming, and local operating companies to ensure the company meets its disclosure requirements. Through collaboration with other BRQC departments and Technology we ensure complete and high quality data is available for timely disclosure of all required studies. The CR team is located in the US and EU and part of the work is performed in an offshore model in India. Recently a temporary position in the team opened up and we are looking for a new CR administrator based in Titusville NJ.
The clinical registry administrator is responsible for submitting and maintaining the clinical trial information and results on various registries. The CR administrator is responsible for set-up, maintenance and closure of the workflow in our registry compliance management system. The CR administrator works with various colleagues to ensure complete and accurate data are available in source systems such as CTMS and TMS/JJAR, that compliance due dates are met, and that high quality data are successfully submitted to external registries. The CR administrator may be responsible for a to-be-determined section of the portfolio. Additional responsibilities include working with an external vendor to ensure patients can be referred from registries to participating trial sites and other tasks as designated to contribute to CR’s goal of global registry-related compliance.

Main responsibilities will include, but are not limited to:

• Identification of studies for assessing registration requirements from source system feeds.
• Setting up studies and workflows in the registry’s compliance management tool PharmaCM
• Identify and follow-up (near) compliance events and ensure timely and complete review, approval and submission of the data is done.
• Submit and maintain registration and results records on registries
• Manage relevant section(s) of the clinical registry administrator central inbox
• Collect and follow up data quality feedback from NIH and other registry related organizations. Ensure timely resolution of raised feedback.
• Prepare overviews and metrics for management.
• Understand data landscape and customer needs for Clinical Registry
• Training of global customers and cross-functional internal training as related to clinical registry
• Maintenance of document repositories where the compliance management system does not provide
• Participates in Clinical Registry Team projects for enhancement of processes, technologies in
use
• Data analysis as required, including support of audits and inspections where registry data are required
• Provides back-up and continuity of urgent registry operations across time zones. This includes follow up of discussions with Clinical Development Team, Operation, Regulatory or others as appropriate, posting of information to public websites
• Works with the off-shore operations team for selected tasks.
• Works with vendor to ensure patients can be referred to participating sites.
Additional responsibilities
• Lead or support CR pharma/cross-segment initiatives, meetings etc. as assigned
• Excellent problem solving and decision making skills
• Strong planning, organizational, and project management skills
• Ability to lead and support project teams and responsible for balance of priorities
INDEPENDENCE / AUTONOMY:
This individual will drive results under the leadership of the Clinical Registry Head. He or she will seek guidance only as needed on new assignments and understand the sense of urgency related to activities. With minimal oversight, he or she will develop and implement strategies related to job description core areas.
REPORTING RELATIONSHIPS:
This position reports to the Clinical Registry Head or designee, Quality Analytics in BRQC Client.
RESPONSIBILITY FOR OTHERS (If applicable):
This individual contributor/leader will not have direct reports, but may lead/support CR initiates or project teams.

WORKING RELATIONSHIPS/INTERFACES:
Principal Relationships Inside the Companies
This leader must be able to effectively operate in a global matrix environment

KNOWLEDGE, EDUCATION, EXPERIENCE, COMMUNICATION SKILL REQUIREMENTS:
Excellent organizational, analytical, strategic, interpersonal, written and oral skills required. Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment is required. Demonstrated strength in influencing and negotiation skills and ability to communicate effectively at all levels of the organization is required. Ability to perform in a team and matrix organization, as well as adapt to a dynamic environment is required. Demonstrated competencies required include industriousness, self-awareness, adaptability, attention to detail, and a high capacity for teamwork. Strong personal leadership with demonstrated competency interfacing with senior leaders, strong networking and relationship building skills is required.

• A Bachelor’s degree in Science, Business, or Computer science / technology or equivalent is required
• A minimum of 3 years of experience in a medium to large scale matrix quality organization (operational quality and/or quality assurance) or equivalent time and experience in a related R&D area (clinical trials, regulatory affairs, data management, data operations and/or statistics) is preferred.
• Demonstrated competency in accurate work with clinical trial or regulatory data, data mgt., programming, scripting or data operations
• Successful global collaborations and partnerships in a globally diverse environment
• Knowledge of procedural and records management requirements in a regulated industry is beneficial.
• Prior experience in a regulated medical industry (Pharmaceutical, Medical Devices, Consumer, CRO and/or Biotech) is required. Experience as senior/GTM CTA, Regulatory submissions coordinator or similar senior administrator roles is preferred
• Prior pharmaceutical and quality/compliance related experience is preferred
• Knowledge of the pre-clinical and clinical drug development process is beneficial
• Excellent knowledge of English is required
• Exceptional written and verbal communications skills
REQUIRED SKILLS:

Leadership experience and skills:
• Strong personal leadership with demonstrated competency interfacing with other team members
• Strong networking and relationship building skills
• Ability to support an open, inviting and creative environment
• Ability to embrace generational differences
• Experience working with multidisciplinary and cross functional persons/teams from Technology, R&D, Medical Safety, Regulatory and Quality functions
• Strong interpersonal skills with demonstrated history of collaboration across multiple functional areas
• Proactive strategic thinker with strong problem solving skills
• Strong conflict management/negotiation skills

Technology experience and skills:
• Experience with Quality and Compliance systems is preferred
• Proficient in Microsoft Office applications
WORKING CONDITIONS/TRAVEL REQUIREMENTS:
Working conditions require resolution of complex problems within tight timelines.

Minimal travel required.
Location at one of the main BRQC hubs with registry presence: Titusville NJ.