Remote jobs san diego
*IRT - Interactive response technologies
*Pharma or Biotech or supplier experience required
*Must have experience designing or maintaining IRT systems for clinical trials
*Candidate will be working remote - open to US Time Zone
The Manager, Clinical Systems (IRT) will work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Study Management, Supply Chain and Data Management functions) and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial. The Manager, Clinical Systems (IRT) will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
Responsibilities:
Serve as the champion and consultant for most efficient and effective IRT design as needed per study protocol
Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts
Design and oversee the development of study-specific IRT technical documents
Document issues and risks, and implement mitigation plans in partnership with study team and technology supplier PM
Identify and track study-related technical issues to resolution
Closely manage project-related timelines and associated activities
Basic Qualifications:
Doctorate Degree
OR
Masters Degree and 3 years of IRT experience
OR
Bachelors Degree and 5 years of IRT experience
OR
Associates degree and 10 years of IRT experience
OR
High school diploma/GED and 12 years of IRT experience
Preferred Qualifications:
5+ years of IRT experience
Bachelors Degree in life science, computer science, engineering, business or related discipline
4+ years of experience in clinical operations, clinical supply chain or clinical systems management
Experience implementing clinical systems, such as IRT and eCOA
Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
Detail-oriented and able to manage many projects simultaneously
Excellent documentation and communication skills
Meeting management and facilitation skills
Vendor management experience
Excellent time management and organization skills in a timeline-driven environment
Sound problem resolution, judgment, and decision-making abilities
Work well in a team-based environment with minimal supervision
Why is the Position Open?
Back fill for another external worker who recently moved into a new position
Top 3 Must Have Skill Sets:
Negotiation with external vendors, management of projects and people, familiarity with documentation in a regulated environment
Employee Value Proposition:
Long term contract with the possibility of extending beyond and there is always the possibility of converting to permanent down the road.
Possible Extension: Yes
Apply Now
*Pharma or Biotech or supplier experience required
*Must have experience designing or maintaining IRT systems for clinical trials
*Candidate will be working remote - open to US Time Zone
The Manager, Clinical Systems (IRT) will work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Study Management, Supply Chain and Data Management functions) and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial. The Manager, Clinical Systems (IRT) will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
Responsibilities:
Serve as the champion and consultant for most efficient and effective IRT design as needed per study protocol
Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts
Design and oversee the development of study-specific IRT technical documents
Document issues and risks, and implement mitigation plans in partnership with study team and technology supplier PM
Identify and track study-related technical issues to resolution
Closely manage project-related timelines and associated activities
Basic Qualifications:
Doctorate Degree
OR
Masters Degree and 3 years of IRT experience
OR
Bachelors Degree and 5 years of IRT experience
OR
Associates degree and 10 years of IRT experience
OR
High school diploma/GED and 12 years of IRT experience
Preferred Qualifications:
5+ years of IRT experience
Bachelors Degree in life science, computer science, engineering, business or related discipline
4+ years of experience in clinical operations, clinical supply chain or clinical systems management
Experience implementing clinical systems, such as IRT and eCOA
Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
Detail-oriented and able to manage many projects simultaneously
Excellent documentation and communication skills
Meeting management and facilitation skills
Vendor management experience
Excellent time management and organization skills in a timeline-driven environment
Sound problem resolution, judgment, and decision-making abilities
Work well in a team-based environment with minimal supervision
Why is the Position Open?
Back fill for another external worker who recently moved into a new position
Top 3 Must Have Skill Sets:
Negotiation with external vendors, management of projects and people, familiarity with documentation in a regulated environment
Employee Value Proposition:
Long term contract with the possibility of extending beyond and there is always the possibility of converting to permanent down the road.
Possible Extension: Yes
Apply Now