Project Coordinator

SUMMARY: 

Zydus Therapeutics, Inc. is seeking a candidate with a minimum of an associate degree. The candidate should have previous experience with trial master file maintenance, auditing, and reconciliation in a healthcare company (insurance provider, medical office, hospital, pharmaceutical company, or contract research organization). The team-member will serve as an integral part of the Clinical Project Team supporting the maintenance of study records and assisting with the coordination of study activities. The candidate will be responsible for development, maintenance, and archiving of files and records related to multiple clinical trials (Trial Master File [TMF] and non-TMF specific), departmental documents, vendor and investigator contact information, and provide administrative support. The role will provide additional support to the Clinical Project Team in various aspect of study start-up, maintenance, and close-out/archival of clinical trials. The position will report directly to Sr, Director, Clinical Project Management or designee. This exciting opening offers the candidate the opportunity to be a part of a professional, customer-focused, pharmaceutical company with a competitive salary and full benefits package. 

Zydus Pharmaceuticals (USA) Inc. is a globally integrated pharmaceutical company with a focus on providing high service, quality, and affordable products. Our parent company, Zydus Lifesciences Limited (also known as Cadila healthcare Limited), has a large presence in global markets, including relationships with many top tier international pharmaceutical companies.  Based on a manufacturing and development history that spans over 50 years, it is the 4th  largest pharmaceutical company in India. Zydus has expanded into development of novel therapeutics and new chemical entities.

RESPONSIBILITIES: 

• Work in conjunction with Project Management team:

o Assist in the planning of Investigators meetings

o Development of required material including training tools

o Initiate contract/budget requests and track the status; negotiate budget with sites and vendors if necessary

o Participate in vendor selection and vendor management

o Identification of changes in scope of work

o Formulate, track, measure and maintain a project specific matrix and timelines

o Support responsibility including scheduling, managing agenda updates and meeting minutes for project team meetings and other meetings, as assigned.

o Provide project support including development of monthly reports, newsletter, project management and communication trackers

o Provide project administrative support including mass site communication distribution, shipping, filing, tracking and status summarization, as appropriate

• Assist in the clinical trial insurance process. Track approvals, revisions and renewals of certificates

• Maintain and track all project specific invoices.

• Ensure smooth site start-up process prior to Site Initiation Visit.

• Assist Clinical Operations team with study management:

o Maintain trial master file, study site records and files and ensure compliance with applicable SOPs

o Review of essential study documents

o Per project requirements, develop project specific procedural documents

o Preparation and shipping of IRB/EC dossiers

o Assist study team on training, as applicable

o Assist in CTMS and other trial related applications training and access management

o Assist the team in preparation of study specific audits and inspections

• Perform all other duties as assigned by senior management

QUALIFICATIONS – SKILLS & REQUIREMENTS: 

• Excellent verbal and written skills.

• Must be well-organized and possess attention to detail.

• Fluent in English, other languages will be noted.

• Proficient with Windows Office (Word, Excel, and PowerPoint). Some measure of flexibility will be necessary.  

• Due to the international framework of the organization, there will be instances when meetings are scheduled during non-traditional workday hours.  

• The ideal candidate must be able to work independently.

• Personal interactions are critical to the role. Must have good inter-relationship skills.

EDUCATION & EXPERIENCE: 

• Minimum of Associate’s Degree or equivalent, Bachelor’s Degree preferred.

• Previous experience in a healthcare company.

• Experience with trial master file maintenance, auditing, and reconciliation preferred.

• Archival of paper files and, if possible, experience auditing archived files.

• Meeting agenda and minute-taking experience.

• Experience interacting with counterparts at Contract Research Organizations and other third-party vendors.

• Experience with Electronic Trial Master File systems.

• Experience in clinical trial management systems.

TRAVEL: 

• This position will have minimal travel requirements. Some travel may occur for off-site meetings or team-building exercises (less than 10%).

WORK ENVIRONMENT: 

This is an office-based position, located at the Zydus Pharmaceuticals office in Pennington, NJ. The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is:

• Frequently required to sit and/or stand, walk, talk, and hear.

• Ability to sit at a computer for an extended period of time.

• Vision ability requirements include clarity of visions at 20 inches or less due to computer work.

• Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic).

• Constantly required to use hands and fingers to operate office machines and equipment.

• Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch.

The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job.