Mgr Sites

Manages the day to day activities, performance and supervision of the research site.Responsible for the effective execution of site protocols and providing daily direction to the site’s staff. Acts as the liaison between the investigator and the research team and ensures the execution and coordination of clinical research activities according to the organization’s SOPs, ICH/GCP and FDA guidelines. Supports the global aligned business objectives, growth, delivery of targets, quality management as well as the appropriate planning and coordinating of resources and facilities.

·Manages site activities to ensure delivery of site targets as received from senior management.

·Provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.

·Responsible for cost control within the site and all vendor contracts for services at the site.

·Continuously oversees the schedules of site staff to ensure highest utilization of all resources.

·Evaluates and implements new operational strategies to enhance efficiencies, provide competitive advantages, and improve overall profitability of the site.

·May provide input in the feasibility process, considering both recruitment and operational concerns.

·Communicates targets to the site teams and continuously measures progress.

·Plans and prepares proactively for future studies according to new and defined strategies, embracing and implementing new TA area initiatives at the sites.

·Collaborates with site and management regarding capacity planning and back-up plans, arranging and attending meetings.

·Ensures patient recruitment activities are adequate for study requirements.

·Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.

·Ensures compliance with the company quality framework, regulatory (GCO) legislation, guidelines and international standards (Global/Local COPS/SOPS).

·Ensure the implementation of quality control methods, practices and improvements and that risks are highlighted to the compliance department.

Ensures that site and facilities provides a safe working environment and is H&S compliant.

Manages the day to day activities, performance and supervision of the research site.Responsible for the effective execution of site protocols and providing daily direction to the site’s staff. Acts as the liaison between the investigator and the research team and ensures the execution and coordination of clinical research activities according to the organization’s SOPs, ICH/GCP and FDA guidelines. Supports the global aligned business objectives, growth, delivery of targets, quality management as well as the appropriate planning and coordinating of resources and facilities.

·Manages site activities to ensure delivery of site targets as received from senior management.

·Provides direct or indirect supervision of all clinical and administrative aspects of a clinical trial within the research site to ensure delivery of targets and quality.

·Responsible for cost control within the site and all vendor contracts for services at the site.

·Continuously oversees the schedules of site staff to ensure highest utilization of all resources.

·Evaluates and implements new operational strategies to enhance efficiencies, provide competitive advantages, and improve overall profitability of the site.

·May provide input in the feasibility process, considering both recruitment and operational concerns.

·Communicates targets to the site teams and continuously measures progress.

·Plans and prepares proactively for future studies according to new and defined strategies, embracing and implementing new TA area initiatives at the sites.

·Collaborates with site and management regarding capacity planning and back-up plans, arranging and attending meetings.

·Ensures patient recruitment activities are adequate for study requirements.

·Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.

·Ensures compliance with the company quality framework, regulatory (GCO) legislation, guidelines and international standards (Global/Local COPS/SOPS).

·Ensure the implementation of quality control methods, practices and improvements and that risks are highlighted to the compliance department.

Ensures that site and facilities provides a safe working environment and is H&S compliant.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).

1 year of leadership responsibility

Knowledge, Skills and Abilities:

·Advanced knowledge of clinical trial processes and expertise / knowledge of clinical study operations

·Advanced knowledge of FDA regulations and ICH GCP guidelines

·Effective understanding of budgeting / forecasting / planning projects

·Strong management and proven leadership skills

·Strong time management skills and ability to work on multiple projects simultaneously

·Strong problem solving and troubleshooting abilities

·Effective written and verbal communication skills

·Proficient in Microsoft Office products

·Capable of acting as a liaison with the client, investigator, study team and other departments/divisions

Management Role:

Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.

Working Conditions and Environment:

·Work is performed in an office and/or a clinical environment with exposure to electrical office equipment.

·Exposure to biological fluids with potential exposure to infectious organisms.

·Occasional drives to site locations, frequent domestic travel and rare international travel.

·Personal protective equipment required such as protective eyewear, garments and gloves.

·Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:

·Frequently vertical and /or stationary for 6-8 hours per day.

·Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

·Frequent mobility required.

·Frequent bendingand twisting ofupper body and neck.

·Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

·Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

·Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

·Frequently interacts with others, relates sensitive information to diverse groups.

·Ability to apply basic principles to solve conceptual issues.

·Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.Ability to perform under stress.Ability to multi-task.

·Regular and consistent attendance.

Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).

1 year of leadership responsibility

Knowledge, Skills and Abilities:

·Advanced knowledge of clinical trial processes and expertise / knowledge of clinical study operations

·Advanced knowledge of FDA regulations and ICH GCP guidelines

·Effective understanding of budgeting / forecasting / planning projects

·Strong management and proven leadership skills

·Strong time management skills and ability to work on multiple projects simultaneously

·Strong problem solving and troubleshooting abilities

·Effective written and verbal communication skills

·Proficient in Microsoft Office products

·Capable of acting as a liaison with the client, investigator, study team and other departments/divisions

Management Role:

Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.

Working Conditions and Environment:

·Work is performed in an office and/or a clinical environment with exposure to electrical office equipment.

·Exposure to biological fluids with potential exposure to infectious organisms.

·Occasional drives to site locations, frequent domestic travel and rare international travel.

·Personal protective equipment required such as protective eyewear, garments and gloves.

·Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:

·Frequently vertical and /or stationary for 6-8 hours per day.

·Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

·Frequent mobility required.

·Frequent bendingand twisting ofupper body and neck.

·Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

·Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

·Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

·Frequently interacts with others, relates sensitive information to diverse groups.

·Ability to apply basic principles to solve conceptual issues.

·Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.Ability to perform under stress.Ability to multi-task.

·Regular and consistent attendance.