Assoc Mgr Sites

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as an Associate Manager Sites And lead a team in overseeing site-based clinical research ensuring compliance with protocols managing staff optimizing site operations and driving the success of our clinical trials and research projects.

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

What Youll Do:
Manage staff which may include interviewing and selection job description preparation professional development goal setting performance management coaching and mentoring employee counseling and separations. Approve courses of action on salary administration hiring corrective action and terminations. Review and approve time records expense reports requests for leave and overtime (if applicable).
Effectively manage multiple key studies to ensure delivery at site level and oversee resource allocation of studies to staff.
Review protocols case report forms and investigators brochures. Collaborate with the management to clarify study questions prior to study start.
Oversee the training and orientation of new team members and other clinic staff in basic research processes new therapeutic areas or unfamiliar study
related procedures.
Provide 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.
Participate in clinic process improvements QA/QC initiatives and issue resolutions.
Participate in the day-to-day clinical study activities and procedures ensuring efficient workflow and appropriate management of research subjects activities.
Ensure study procedures are performed safely and in compliance with study protocols SOPs work instructions GCP FDA and other applicable regulations.
Revies client protocols and case report forms for in-house comprehensive source documentation and logistical feasibility.
Assist in the development and presentation of departmental and clinic training.
Oversee the management and procurement of departmental supplies and equipment.

Education and Experience:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 0 to 5 years).
1 year of leadership responsibility

In 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:
Directly supervises individual contributors administrative support and / or entry-level professionals.
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 PPDs eTMF process and the DIA eTMF Reference Model
Sound knowledge of organizations 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 preparedness

Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Frequently drives to site locations and frequently travels both domestic and international.
Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development LLC a Delaware limited liability company (PPD) collectively made up of Acurian Inc. and Synexus each a subsidiary of PPD.

Physical Requirements:
Frequently 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.
Moderate mobility required.
Occasional crouching stooping bending and twisting of upper 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.
Able to communicate 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 interacting with others relates sensitive information to diverse groups both internally & externally.
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.

Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experience and where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthrough.