Program Manager in Gaithersburg, MD at DISYS

Date Posted: 7/3/2018

Job Snapshot

Job Description

TITLE                         -  Associate Project / Programme Manager (Remote)


LOCATION                 - Gaithersburg, MD


CONTRACT               -  1 year


 


Candidate Focus & Challenge :
• Collaborate with the Programming Leader to provide support for aspects of the clinical development process, including clinical development plans, regulatory submissions, commercialisation and scientific utilisation data for AZ products.
• Collaborate with the Programming Leader to provide programming support to deliver technical programming and information components of a project, including but not limited to:
o Regulatory response to agency queries
o Development Safety Update Reports (DSUR)
o Periodic Benefit-Risk Evaluation Report (PBRER)
o Investigators brochures (IB)
o Data submission strategy, i.e., legacy data, pooling data, communications with regulatory agencies
o Outcomes studies
o Pharmacokinetics/pharmacodynamics data preparation and analysis
o Manipulating and analyzing adjudicated data
o Delivering Clinical Trial Transparency (data de- identification)
o Data preparation and analysis for Global Medical Affairs work
• Produce and maintain the technical database standards and Programming Specification documents
• Contribute to the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners
• Provide support to the regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions
• Identify opportunities to improve the methodology and provide practical solutions for problems
• Contribute to the development of best practice to improve quality, efficiency and effectiveness

Candidate Knowledge, Skills & Experience:
Values:
o Contributes to innovating and streamlining workflows.
o Knowledgeable of the drug indications within a therapeutic area and data submission standards within that therapeutic area.
o Contributes to assessing and mitigating risk within a protocol or drug project and proactively determining the need and/or level of escalation
• BSc in Mathematical, Statistical, Computer Science or Life Science
• Extensive SAS programming experience
• Knowledge of database set-up and report publishing requirements
• Knowledge of technical and regulatory requirements related to the role
• Knowledge of CDSIC standard and industry best practices
• Experience in clinical drug development or healthcare
• Excellent verbal and written communication skills
• Assist in developing and delivering training

Job Dimensions:
• Leadership role able to lead and direct elements of project work
• Accountable for the quality of elements of project programming work
• Accountable for good Information Practice
• Reports to Programming Team Leader

Other :
Behaviors:
o Team commitment: prioritise attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team. Be proactive Excellent collaboration required – needs the energy to work across global & functional boundaries
o Decision making: constructively challenge others and be receptive to challenge in bringing clarity and robustness (evidence based) to decision making within the team
o Issue resolution: work collaboratively with the project team to resolve issues, irrespective of whether or not the issues are functional in nature
o Communication: agree on how to communicate decisions, successes and escalation of issues etc. – speak with one voice instead of separate roles.
• Collaboration required
• Ability to apply programming expertise to problems, problem solving and quality focus.
• Other programming languages e.g. S-PLUS, R, XML etc.
• Familiarity with Open CDISC Validator



If interested, please send me your updated resume.



Looking forward for your response.

Job Requirements

TITLE                         -  Associate Project / Programme Manager (Remote)


LOCATION                 - Gaithersburg, MD


CONTRACT               -  1 year


 


Candidate Focus & Challenge :
• Collaborate with the Programming Leader to provide support for aspects of the clinical development process, including clinical development plans, regulatory submissions, commercialisation and scientific utilisation data for AZ products.
• Collaborate with the Programming Leader to provide programming support to deliver technical programming and information components of a project, including but not limited to:
o Regulatory response to agency queries
o Development Safety Update Reports (DSUR)
o Periodic Benefit-Risk Evaluation Report (PBRER)
o Investigators brochures (IB)
o Data submission strategy, i.e., legacy data, pooling data, communications with regulatory agencies
o Outcomes studies
o Pharmacokinetics/pharmacodynamics data preparation and analysis
o Manipulating and analyzing adjudicated data
o Delivering Clinical Trial Transparency (data de- identification)
o Data preparation and analysis for Global Medical Affairs work
• Produce and maintain the technical database standards and Programming Specification documents
• Contribute to the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners
• Provide support to the regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions
• Identify opportunities to improve the methodology and provide practical solutions for problems
• Contribute to the development of best practice to improve quality, efficiency and effectiveness

Candidate Knowledge, Skills & Experience:
Values:
o Contributes to innovating and streamlining workflows.
o Knowledgeable of the drug indications within a therapeutic area and data submission standards within that therapeutic area.
o Contributes to assessing and mitigating risk within a protocol or drug project and proactively determining the need and/or level of escalation
• BSc in Mathematical, Statistical, Computer Science or Life Science
• Extensive SAS programming experience
• Knowledge of database set-up and report publishing requirements
• Knowledge of technical and regulatory requirements related to the role
• Knowledge of CDSIC standard and industry best practices
• Experience in clinical drug development or healthcare
• Excellent verbal and written communication skills
• Assist in developing and delivering training

Job Dimensions:
• Leadership role able to lead and direct elements of project work
• Accountable for the quality of elements of project programming work
• Accountable for good Information Practice
• Reports to Programming Team Leader

Other :
Behaviors:
o Team commitment: prioritise attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team. Be proactive Excellent collaboration required – needs the energy to work across global & functional boundaries
o Decision making: constructively challenge others and be receptive to challenge in bringing clarity and robustness (evidence based) to decision making within the team
o Issue resolution: work collaboratively with the project team to resolve issues, irrespective of whether or not the issues are functional in nature
o Communication: agree on how to communicate decisions, successes and escalation of issues etc. – speak with one voice instead of separate roles.
• Collaboration required
• Ability to apply programming expertise to problems, problem solving and quality focus.
• Other programming languages e.g. S-PLUS, R, XML etc.
• Familiarity with Open CDISC Validator



If interested, please send me your updated resume.



Looking forward for your response.

Digital Intelligence Systems, LLC. is an Equal Opportunity Employer, M/F/D/V. We do not discriminate against any employee or applicant because they inquired about, discussed, or disclosed compensation. Email recruitinghelp @ disys.com to contact us if you are an individual with a disability and require accommodation in the application process.