ob Title : Program Manager
Location: Boston, MA.
Skill Required: Central Designer, InForm Central Designer
PRIMARY DUTIES AND RESPONSIBILITIES:
• Provide a high level of customer support to DF/HCC stakeholders, including study teams, clinicians, Office of Data Quality, Office for Human Research Studies, Clinical Trials Office, Clinical Trials Business Office, Partners eCare and others by either resolving issues or facilitating connection with appropriate resources.
• Build electronic case reports forms (eCRFs) utilizing Central Designer™
o Gather study data collection requirements from the protocol document and from meetings with the study team (PI, biostatistician, Lead Coordinator and/or Research Project Manager)
o Convert requirements into sample eCRFs and build studies in Central Designer™
o Use templates and libraries in Central Designer™ to leverage existing EDC portfolio
o Program edit checks and global conditions as needed
o Perform basic test of the study in the InForm QA environment
• Build protocol treatment arms and calendars
o Gather, analyze, and assimilate documents required to build calendars and treatment arms in the DF/HCC clinical trials management system, OnCore. (i.e., research protocols, cohorts, treatment arms, etc.) and protocols in caTissue.
o Collaborate with study teams and clinical staff to create and update calendars and treatment arms in OnCore.
o Identify obstacles encountered during the calendar build process; communicate and develop acceptable resolutions to such obstacles.
o Understand various software systems and the interdependencies between them to guide calendar creation.
o Educates study team members on how subject enrollment, treatment arms and calendars work.
• Manage all aspects of the project: team communications, timelines, signoffs, scope changes, etc.
• Adhere to recognized project management tools and methodologies.
• Write and maintain detailed documentation of requirements and project communications.
• Identify and resolve issues, and facilitate appropriate escalation for timely reso
• Bachelor's degree required. Concentration in Computer Science, Business, IT, Healthcare, Biology or other relevant healthcare or life sciences related field preferred; background in a health care and/or clinical trials strongly preferred.
• Proven analytical, systems design and technical project management skills
• 4+ years of direct analytical work experience as a business or applications analyst, or data manager, in an academic and/or healthcare setting.
• Experience in leading cross-functional teams of 5 or more indirect resources, including directing the work of user and business representatives within workgroups
• Clinical research and/or clinical trials data management preferred
• Formal business analyst and/or project management training a plus
• Proficient in complete MS Office suite, including Outlook, Word, Excel, and PowerPoint.
• A combination of education and experience may be substituted for requirements
• Strong technical skills including analysis, design and testing
• Attention to detail, customer service orientation, and proven ability to perform work accurately and efficiently.
• Ability to be flexible, versatile and adaptable in activities conducted in a multi-site environment
• Excellent interpersonal skills. Must be able to effectively communicate and collaborate with staff of different skill sets, backgrounds and levels within and external to the organization, including both technical and nontechnical personnel.
• Ability to effectively conduct meetings, both formal and informal.
• Ability to work under stress due to tight deadlines and unanticipated scope changes.
• Ability to work and maintain focus within a complex work environment with shifting and competing priorities.
• Excellent project management skills. Ability to handle multiple projects at any given time and prioritize as necessary.
• Exceptional problem solving and negotiation skills, with demonstrated analytical and reasoning skills
• Must be willing to contribute to and foster a team culture where all are encouraged and willing to share information accurately.
• Have a thorough understanding of clinical trial study development, including analysis, requirements gathering, design, and testing; expertise in oncology clinical trials desirable.
• Understanding of data management highly desired.
• Understand requirements involved in human subjects research.
• Ability to learn quickly
• Self-motivated and capable of working independently
Central Business Solutions, Inc,
37600 Central Ct.
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (833)247-8800 Fax: (510)-740-3677