Clinical Supplies Project Coordinator
The Clinical Supplies Project Coordinator (CSPC) assists with organizing all activities involved with the management of clinical supplies.
This includes but is not limited to the following services:
procurement, formulation/development, manufacturing, packaging, distribution, and analytical services.
It is the responsibility of the CSPC to define the scope and timeline of the requested services and coordinate all internal and external communication related to each project.
Essential Duties and Responsibilities Comply with cGMP guidelines Communicate necessary information to all appropriate departments for the purpose of initiating the quoting process Prepare and assist with formal quoting Track and maintain project management reporting logs Support Clinical Supplies Project Managers/ Sr.
Project Managers as needed Prepare project timeline with input from key operating departments and business partner Identify components required as per business partner needs and submit requests for procurement Write Manufacturing Instructions (MI) in compliance with cGMPs and SOPs in a timely, accurate and concise manner Document background information for all projects and maintains complete record files Assist in collaboration with key operating departments to meet internal deadlines for timely completion of requested activities Work with colleagues to resolve potential conflicts with projects Perform and assist with SAP entries Inform management and business partners of project delays and recommend appropriate solutions.
QualificationsTo perform this job successfully, an individual must be able to perform each essential duty.
The minimum requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Associates or Bachelors' Degree in the sciences and/or related experience.
1 - 3 years in experience in Project Management, preferably in pharmaceutical clinical supplies or clinical research/supply environment.
Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.
Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.
Preferred knowledgeable of cGMPs, FDA , DEA and OSHA Regulations and ISO guidelines.
Basic knowledge of drug product nomenclature and drug development process.
Strong ability to contribute and function in a team environment to achieve Company goals.
Working knowledge of personal computers and Microsoft Office Products, including Word, MS Project and Excel.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel and talk or hear and frequently required to sit.
Employee is occasionally required stand, walk and reach with hands and arms.
The employee must occasionally lift and/or move up to 10 pounds.
Specific vision abilities required by this job include close, distance and ability to adjust focus.
Recommended Skills Clinical Research Clinical Works Drug Development Ms Project Microsoft Office Pharmaceuticals Estimated Salary: $20 to $28 per hour based on qualifications.
This includes but is not limited to the following services:
procurement, formulation/development, manufacturing, packaging, distribution, and analytical services.
It is the responsibility of the CSPC to define the scope and timeline of the requested services and coordinate all internal and external communication related to each project.
Essential Duties and Responsibilities Comply with cGMP guidelines Communicate necessary information to all appropriate departments for the purpose of initiating the quoting process Prepare and assist with formal quoting Track and maintain project management reporting logs Support Clinical Supplies Project Managers/ Sr.
Project Managers as needed Prepare project timeline with input from key operating departments and business partner Identify components required as per business partner needs and submit requests for procurement Write Manufacturing Instructions (MI) in compliance with cGMPs and SOPs in a timely, accurate and concise manner Document background information for all projects and maintains complete record files Assist in collaboration with key operating departments to meet internal deadlines for timely completion of requested activities Work with colleagues to resolve potential conflicts with projects Perform and assist with SAP entries Inform management and business partners of project delays and recommend appropriate solutions.
QualificationsTo perform this job successfully, an individual must be able to perform each essential duty.
The minimum requirements listed below are representative of the knowledge, skill, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Associates or Bachelors' Degree in the sciences and/or related experience.
1 - 3 years in experience in Project Management, preferably in pharmaceutical clinical supplies or clinical research/supply environment.
Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.
Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.
Preferred knowledgeable of cGMPs, FDA , DEA and OSHA Regulations and ISO guidelines.
Basic knowledge of drug product nomenclature and drug development process.
Strong ability to contribute and function in a team environment to achieve Company goals.
Working knowledge of personal computers and Microsoft Office Products, including Word, MS Project and Excel.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle or feel and talk or hear and frequently required to sit.
Employee is occasionally required stand, walk and reach with hands and arms.
The employee must occasionally lift and/or move up to 10 pounds.
Specific vision abilities required by this job include close, distance and ability to adjust focus.
Recommended Skills Clinical Research Clinical Works Drug Development Ms Project Microsoft Office Pharmaceuticals Estimated Salary: $20 to $28 per hour based on qualifications.
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