Assoc Mgr Sites

Pharmaceutical Product Development (PPD)

FL-Orlando-Orlando FL


Summarized Purpose:

Manages a small site or team and provides leadership and supervision during the conduct of clinical trials for accuracy, data integrity and safety to clinical staff. Attends process improvement meetings and participates in various committees within the clinic in an effort to improve processes and streamline efficiencies. Assists with QA/QC initiatives as needed.

Essential Functions and Other Job Information:

Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, 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 (if applicable).• Effectively manages multiple key studies to ensure delivery at site level and oversees resource allocation of studies to staff.• Reviews protocols, case report forms and investigator's brochures. Collaborates with the management to clarify study questions prior to study start.• Oversees the training and orientation of new team members and other clinic staff in basic research processes, new therapeutic areas or unfamiliar study related procedures.• Provides leadership and supervision of clinical staff within the research sites, ensuring that all study related tasks are properly planned and executed with adequately trained and skilled team members.• Participates in clinic process improvements, QA/QC initiatives and issue resolutions.• Participates in the day-to-day clinical study activities and procedures, ensuring efficient work flow and appropriate management of research subject’s activities.• Ensures study procedures are performed safely and in compliance with study protocols, SOPs, work instructions, GCP, FDA and other applicable regulations.• Reviews client protocols and case report forms for in-house comprehensive source documentation and logistical feasibility.• Assists in the development and presentation of departmental and clinic training.• Oversees the management and procurement of departmental supplies and equipment.Summarized Purpose:

Manages a small site or team and provides leadership and supervision during the conduct of clinical trials for accuracy, data integrity and safety to clinical staff. Attends process improvement meetings and participates in various committees within the clinic in an effort to improve processes and streamline efficiencies. Assists with QA/QC initiatives as needed.

Essential Functions and Other Job Information:

Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, 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 (if applicable).• Effectively manages multiple key studies to ensure delivery at site level and oversees resource allocation of studies to staff.• Reviews protocols, case report forms and investigator's brochures. Collaborates with the management to clarify study questions prior to study start.• Oversees the training and orientation of new team members and other clinic staff in basic research processes, new therapeutic areas or unfamiliar study related procedures.• Provides leadership and supervision of clinical staff within the research sites, ensuring that all study related tasks are properly planned and executed with adequately trained and skilled team members.• Participates in clinic process improvements, QA/QC initiatives and issue resolutions.• Participates in the day-to-day clinical study activities and procedures, ensuring efficient work flow and appropriate management of research subject’s activities.• Ensures study procedures are performed safely and in compliance with study protocols, SOPs, work instructions, GCP, FDA and other applicable regulations.• Reviews client protocols and case report forms for in-house comprehensive source documentation and logistical feasibility.• Assists in the development and presentation of departmental and clinic training.• Oversees the management and procurement of departmental supplies and equipment.Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years).1 year of leadership responsibilityIn some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:• Fundamental communication and interpersonal skills with the ability to manage, motivate and mentor staff• Strong organization skills with ability to handle multiple tasks simultaneously, meet rigorous timelines and work effectively in stressful situations• Understanding of budgets, project planning and performance metrics• Strong English and grammar skills, second language a plus• Sound knowledge of taxonomies (e.g. folder structures, metadata, user access) and/or Records Management principles including but not limited to: FDA Good Clinical Practices; ICH Guidelines and PPDs Standard Operating Procedures and Working Practice Documents; retention schedules; Legal Holds; supporting software and/or PPD's eTMF process and the DIA eTMF Reference Model• Sound knowledge of organization's archival processes and systems (hardware, software, applications, operating systems, basic programming languages, etc.)• Ability to manage the day-to-day operation of Records Management file rooms including but not limited to document control, security and audit preparednessManagement Role:Directly supervises individual contributors, administrative support and / or entry-level professionals.Qualifications:

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years).1 year of leadership responsibilityIn some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:• Fundamental communication and interpersonal skills with the ability to manage, motivate and mentor staff• Strong organization skills with ability to handle multiple tasks simultaneously, meet rigorous timelines and work effectively in stressful situations• Understanding of budgets, project planning and performance metrics• Strong English and grammar skills, second language a plus• Sound knowledge of taxonomies (e.g. folder structures, metadata, user access) and/or Records Management principles including but not limited to: FDA Good Clinical Practices; ICH Guidelines and PPDs Standard Operating Procedures and Working Practice Documents; retention schedules; Legal Holds; supporting software and/or PPD's eTMF process and the DIA eTMF Reference Model• Sound knowledge of organization's archival processes and systems (hardware, software, applications, operating systems, basic programming languages, etc.)• Ability to manage the day-to-day operation of Records Management file rooms including but not limited to document control, security and audit preparednessManagement Role:Directly supervises individual contributors, administrative support and / or entry-level professionals.


2020-11-20 00:00:00


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