Sr Manager, Clinical Systems Administrator Job

Organization
Celgene Corporation
Job Location
Berkeley Heights, NJ
Job Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary/Scope:
- Primary point of contact for a Clinical System or systems user community to provide detailed system oversight and support, training and process guidance. Resident expert on clinical system, functional capabilities and relevant business processes enabled by the system.

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

System Oversight

- Directs the day-to-day business usage of the system; communicates and coordinates between all impacted internal and external users of clinical systems
- Lead relationship with Information Technology (IT) and clinical system vendors
- Identification and oversight of remediation for bug fixes, change requests and other system upgrades by IT
- Collaborates with IT and other relevant system owners (ie. IVRS, eDC, CELALERT, CELECT) to create and manage definitions associated with the data to be collected/reported in the system; reinforces master data management principles and methodologies required to protect integrity of system data.
- Interact with process owners and end users to understand system interfaces, usability, and data integrity.
- Development and execution of User Acceptance Testing ( UAT), including development and publication of use cases and other testing procedures in partnership with IT
- Coordinating activities of end users in system life cycle management activities including collection and documentation of business requirements for data capture, system functionality, system navigation and reporting needs
- Supports end users with execution of system upgrades
- Triages or answers system and business process related system questions
- Troubleshoot with IT and Central Services Leadership on integrations with other systems (i.e. IVRS) and identify/resolve issues as appropriate
- Establishes criteria for controlling user access to the various features of the system including the prerequisites required to be met prior to granting user access to specific system roles and act as an escalation point for system access related issues
- Complete other system related tasks as required

Training and Change Management

- Ensures that those who need to use the system have access to user training and system documentation; works with training function to identify training needs, and develop and deploy training to required audiences
- Generates or supports generation of training materials inclusive of relevant user guides or job aides that define data collection and reporting standards
- Establishes and directs user forums or other interactive methods to train and engage the user community
- Establishes, trains, and supports clinical system super-user community through periodic meetings, communications and day to day interactions.

Process Guidance

- Develop and implement systems related business processes that complement the business practices enabled via the system.
- Drive consistent, standardized system usage, such as electronic monitoring visit reports and compliance with entry/execution timelines of key aspects of clinical systems (i.e. distribution of SUSARs, milestone maintenance)
- Develops, maintains, and/or reviews clinical system administrative manual, user guides, Frequently Asked Questions log, newsletter, website or other modality for information sharing with the user community
- Participates in process updates throughout the organization as it pertains to relevant clinical system
- Administers a centralized mailbox to address, resolve or triage issues and requests from the internal and external clinical system user community

Skills/Knowledge Required:
- Highly familiar with systems and processes related to Clinical Trial Management.
- Strong understanding of global management of clinical studies and the clinical drug development process, regulations and guidelines
- Prior experience in a clinical research and development operations role (e.g. Study Manager, CRA, or CTA/CSA)
- Previous experience with entry and data management within clinical systems e.g. Document Management Systems, CTMS, EDC, IVRS, Investigator Portals
- Advanced knowledge of System Development Life Cycle Methodology
- Computer literate; familiarity with Microsoft Office programs including Microsoft Project, commonly used technologies for clinical trials, and reporting/analytic software
- Demonstrated ability to diagnose and resolve issues proactively and independently in a fast paced environment
- Advanced ability to multitask complex projects from multiple sources
- Attention to detail
- Strong communication skills and ability to interact across multiple functional areas, including IT; ability to present and explain technical information in a simplified manner to support user community training and overall compliance

Leadership Competencies:

Foster Teamwork –
- Collaborates with people from other teams, functions, and geographies as needed to get work done
- Handles conflicts with others in a constructive manner
- Solicits and offers feedback on how people could work more effectively together

Foster Risk Taking –
- Considers the benefits and risks when suggesting a new idea or methodology
- Displays a willingness to challenge the status quo and take risks

Demonstrate Adaptability –
- Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute
- Asks question to better understand the rationale for and benefits of change
- Maintains optimism and composure in times of change, uncertainty, or stress
- Deals constructively with mistakes and setbacks
- Maintains a high level of performance in the face of ambiguity or change
- Responds openly to feedback viewing suggestions as learning opportunities
- Accepts challenging assignments and new responsibilities

Promote Open Communication –
- Clearly articulates ideas opinions, and information
- Listens to others’ viewpoints and asks questions to clarify for understanding
- Encourages open exchange of information and viewpoints
- Uses different communication methods appropriately (e.g., email, voice mail,face-to-face)
- Promptly communicates information that others need to know in order to do their jobs

Create Global Mindset –
- Considers global influences, situations, and implications both inside and outside the organization when making plans or decisions, solving problems, or developing strategies
- Develops and maintains effective working relationships with people across cultures
- Demonstrates cross-cultural sensitivity when working with others
- Understands and utilizes knowledge of local business practices when working across cultures

Attract and Develop Talent –
- Learns from both successes and failures
- Seeks both formal and informal development opportunities
- Serves as a resource for others’ development by sharing knowledge/skills in areas of expertise

Shape Strategy -
- Demonstrates basic understanding of the external environment and its implications for Celgene’s goals and strategies
- Seeks to understand the company’s vision and strategies and how his/her work contributes to reaching it
- Maintains focus on work that is most important to accomplishing Celgene’s operational goals

Drive Innovation -
- Contributes openly and honestly when new ideas or initiatives are being debated
- Evaluates others’ ideas and communicates both support and concerns in a professional manner
- Continually works to improve products, services, and work processes
- Identifies and/or supports new solutions, opportunities, and initiatives

Drive Execution -
- Stays focused on highest priority activities, effectively managing time and workload
- Maintains high quality while meeting deadlines and commitments
- Keeps manager informed of progress and seeks guidance when deadlines or goals are in jeopardy
- Demonstrates a concern for the needs and expectations of internal and/or external customers
- Makes timely decisions based on accurate logic; looks beyond symptoms to identify causes of problems; makes decisions in the face of uncertainty; takes all important issues into account when making decisions.
- Meets commitments to customers/clients; continually searches for ways to improve customer/client service; impresses customers with exceptional service or work; seeks feedback from customers.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

*LI-JW1

Qualifications
BA/BS or equivalent degree in life sciences or allied health field
At least 5years of experience in clinical operations roles and prior experience in management or oversight of a Clinical System

Req ID: 15001997
Primary Location: United States-New Jersey-Berkeley Heights
Job: Medical Affairs
Organization: Celgene Corporation
Schedule: Regular
Shift: Standard
Employee Status: Manager
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 10 % of the Time
Job Posting: 2015-11-01 00:00:00.0

Requirements: 

Change Management, Clinic, Clinical Research, Data, Data Management, Document Management, Healthcare, Management, Manager, Medical, Medical Research, R&D, Research, System Administrator, Technology, Testing

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