Assoc Clinical Research Manager

Company Overview:

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

Our colleagues in corporate strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

Role Summary:

The AssocClinical Research Managerassists with managing various aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between senior project team members and study subjects. Actively participates and assists with sponsor, investigator and research team communications. Actively participates with senior project team members to meet project needs, projections and deadlines. Oversees organization and accuracy of project documents. Works with management on understanding departmental needs and improving processes. Provides support for the study conduct, working directly with study monitor and study subjects. Oversees data entry, source data QC, EDC data entry and EDC query resolution, lab data verification, subject eligibility status review and subject eligibility notification.

Company Overview:

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

Our colleagues in corporate strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

Role Summary:

The AssocClinical Research Managerassists with managing various aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between senior project team members and study subjects. Actively participates and assists with sponsor, investigator and research team communications. Actively participates with senior project team members to meet project needs, projections and deadlines. Oversees organization and accuracy of project documents. Works with management on understanding departmental needs and improving processes. Provides support for the study conduct, working directly with study monitor and study subjects. Oversees data entry, source data QC, EDC data entry and EDC query resolution, lab data verification, subject eligibility status review and subject eligibility notification.

Education:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification or previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years) Basic knowledge of Phase I processes and clinical study operations Fundamental knowledge of FDA regulations and ICH GCP guidelines Basic computer skills with working knowledge of Microsoft Office applications Time management and multi-tasking skills Written and verbal communication skills Ability to prioritize workload and adapt to changing study needs Ability to act as a liaison between external and internal groups

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Education:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification or previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years) Basic knowledge of Phase I processes and clinical study operations Fundamental knowledge of FDA regulations and ICH GCP guidelines Basic computer skills with working knowledge of Microsoft Office applications Time management and multi-tasking skills Written and verbal communication skills Ability to prioritize workload and adapt to changing study needs Ability to act as a liaison between external and internal groups

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.