Minimum requirements:
Job Description:
Summary of Responsibilities
This position is responsible for the clinical planning and implementation for all aspects of the management of clinical operations for one or more complex domestic or global clinical trials. Performs assigned responsibilities to ensure timely completion of company and department goals and objectives with minimum supervision. Manages one or more direct reports. Disseminates clinical information to the clinical team members and Associate Director as appropriate
Essential Function
1. Accountable for the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) from study start up to study completion including relevant regulatory requirements
2. Participate in the review and determination of appropriate site and vendor selection
3. Ensures assigned clinical trials meet the predetermined program milestones
4. Interacts with internal/ external groups (CROs, vendors, clinical sites, etc.)
5. Accountable for study timelines, clinical trial budgets, development of relevant study plans/documents
6. Oversees monitoring report reviews and approval
7. Review updates to annual reports, IB, etc. from the clinical trial prospective
8. Responsible for Investigator Meeting coordination and participation
9. Responsible for coordination of the review of clinical trial data
10. Participates in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies
11. Participates in special projects as appropriate
12. Maintains professional and technical knowledge by staying current on pharmaceuticals industry research and developments as appropriate; by utilizing the resources made available by the Company; and by sharing information with colleagues
13. Escalates issues as appropriate to the Associate Director
14. Acts on constructive feedback to improve performance and provides feedback to direct reports and colleagues
15. Responsible for the recruitment, training and development, performance management and resource management of staff
Education level and/or relevant experience(s):
Bachelor's degree from a four-year university or college; and six to ten years work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience.
Knowledge and skills (general and technical):
• Extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP
• Familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting Ability to manage complex and global clinical trials
• Excellent written and oral communication skills in order to effectively communicate in English. Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English
• Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English. Ability to write reports, business correspondence and procedure manuals in English
• Ability to effectively present information to and respond to questions from groups of managers, sites, etc.
• Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Must be tactful, mature, flexible, and have well-developed interpersonal skills
• Ability to get along well with different personalities and to work well in teams
• Must have demonstrated ability to work independently and in a team, and provide leadership in a management role
• Must have experience interfacing and managing multiple vendors/ contractors
• Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule
• Computer skills needed include strong knowledge of database and word processing: MS Word, MS Project, PowerPoint, and Excel
Job Description:
Summary of Responsibilities
This position is responsible for the clinical planning and implementation for all aspects of the management of clinical operations for one or more complex domestic or global clinical trials. Performs assigned responsibilities to ensure timely completion of company and department goals and objectives with minimum supervision. Manages one or more direct reports. Disseminates clinical information to the clinical team members and Associate Director as appropriate
Essential Function
1. Accountable for the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) from study start up to study completion including relevant regulatory requirements
2. Participate in the review and determination of appropriate site and vendor selection
3. Ensures assigned clinical trials meet the predetermined program milestones
4. Interacts with internal/ external groups (CROs, vendors, clinical sites, etc.)
5. Accountable for study timelines, clinical trial budgets, development of relevant study plans/documents
6. Oversees monitoring report reviews and approval
7. Review updates to annual reports, IB, etc. from the clinical trial prospective
8. Responsible for Investigator Meeting coordination and participation
9. Responsible for coordination of the review of clinical trial data
10. Participates in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies
11. Participates in special projects as appropriate
12. Maintains professional and technical knowledge by staying current on pharmaceuticals industry research and developments as appropriate; by utilizing the resources made available by the Company; and by sharing information with colleagues
13. Escalates issues as appropriate to the Associate Director
14. Acts on constructive feedback to improve performance and provides feedback to direct reports and colleagues
15. Responsible for the recruitment, training and development, performance management and resource management of staff
Education level and/or relevant experience(s):
Bachelor's degree from a four-year university or college; and six to ten years work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience.
Knowledge and skills (general and technical):
• Extensive knowledge of clinical development principles, theories and concepts and knowledge of pharmaceutical industry practices and standards, including GCP
• Familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting Ability to manage complex and global clinical trials
• Excellent written and oral communication skills in order to effectively communicate in English. Ability to communicate in medical and scientific terms with vendors, consultants, and peers in English
• Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations in English. Ability to write reports, business correspondence and procedure manuals in English
• Ability to effectively present information to and respond to questions from groups of managers, sites, etc.
• Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Must be tactful, mature, flexible, and have well-developed interpersonal skills
• Ability to get along well with different personalities and to work well in teams
• Must have demonstrated ability to work independently and in a team, and provide leadership in a management role
• Must have experience interfacing and managing multiple vendors/ contractors
• Ability to manage time, multi-task and prioritize in order to complete deliverables on schedule
• Computer skills needed include strong knowledge of database and word processing: MS Word, MS Project, PowerPoint, and Excel