Oncology Project Manager II

Description

MERIT CRO, Inc. is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We’re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities

MERIT is seeking a full-time Project Manager to accomplishes the day-to-day operations of project management and accurately and competently administers activities regarding assigned studies. Responsible for all study activities; study start up through closeout. Primary functions include assisting project team management of clinical trial data in the EXCELSIOR™ cloud application environment; perform data upload, quality control functions; maintenance of controlled documents including Master Project Files; and provide support functions for clinical sites, reading centers and clients using EXCELSIOR according to MERIT and/or study specific procedures and Good Clinical Practices (GCP).

ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)

Administrative Duties:

• Manage office tasks including organization and coordination of controlled documents
• Assist in development of project and regulatory documents; includes proofreading of documents
• Respond to quality review audits and clearly document responses to facilitate resolutions
• Assist with the development/implementation of training programs
• Monitor own work to ensure quality and completeness
•  Ability to work with limited supervision
•  Ability to mentor and help train other team members, as needed
  

Study-Related Duties:

• Perform and oversee all study activities from start-up through close out and data lock
• Organize and prioritize work assignments to complete assignments and tasks on time and with quality, and has the      ability to anticipate problem areas in advance Apply creative approaches and ideas to solve problems maximizing effective use of appropriate resources
• Prepare study start up materials, organize and conduct internal study start up meeting, and follow up on action items
• Establish and maintain routine communication among internal MERIT departments, sponsors, site staff, and other      designated parties
• Assist with the development of new study specific processes and procedures
• Initiation of Master Project File and maintenance of project documents
• Establish study files and create and distribute study documents
• Attend project meetings internally and with sponsor (via teleconference or face-to-face) throughout the project
• Maintain established study specific systems and procedures for regular status updates, site information lists, revisions of plans or study documents and routine correspondence.
• Generate and email eligibility and progression confirmation reports and notifications 
• Generate and provide study reports and updates
• Independently process clinical data from start up through database lock prioritizing work to meet project timelines
• Responsible for assisting in all aspects of study conduct, initiation through closeout

Software-related Duties:

• Understand the EXCELSIOR product, protocol, and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with study team members and sponsors
• Provide guidance and training to sponsors, CROs, and clinical sites on the use of EXCELSIOR, including software      functionality and technical support
• Ensure accurate and efficient set up of EXCELSIOR for assigned project(s) through reviews, user acceptance testing, and study specific imaging charter review and development
• Work closely with the POM group to complete the initial configuration of studies within EXCELSIOR 
• Assist with the review of EXCELSIOR study specific configuration
• Develop and perform project specific user acceptance testing, involving reading center personnel as applicable
• Ensure the internal team is appropriately trained in the use of EXCELSIOR, and if required, provide additional training support and development
• Manage and review site surveys, update EXCELSIOR for site registration
• Clinical site technologist and equipment certification as needed
• Image check-in and quality control as needed
• Issue and review data query responses to ensure completeness and accuracy of response relative to other data
• Review, categorize, and respond to customer support and complaint tickets in the helpdesk application
• Follow up with sites, sponsors, and readers on EXCELSIOR access; review inactive user reports

Other:

• Comply fully with company policies and Standard Operating Procedures (SOPs)
• Other responsibilities may be assigned as required

The following are the essential functions of the position but are not all-inclusive.

• Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.
• Demonstrates a commitment to maintain safe, clean, and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.

Requirements

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The 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.

Education and Experience:

Minimum of a Bachelor’s degree in a health related, biological science, computer science, data entry, customer service or business management is preferred, or an equivalent combination of education, training, and work experience. 

A minimum of three (3) years of clinical trial or project management experience in a related field.

Other Skills and Abilities:

Strong interpersonal and organizational skills, excellent attention to detail, ability to follow direction, assess Company needs and work independently. Computer skills to include proficiency in Microsoft Office software and ability to learn Company specific software. Must be able to project a professional attitude and image appropriate for the work environment.

Ability to participate and contribute in a team environment as a team member. Oral and written communication is clear, concise, and effective. 

Licenses or Certifications Required: None.

Physical Requirements: 

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 touch, finger and grasp, handle or feel, with repetitive motions, and talk or hear. The employee is frequently required to stand, walk, and sit. The employee is occasionally required to reach with hands and arms, stoop, crouch, kneel and climb. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. 

Work Environment:

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

Benefits Offered: 

Retirment 401(k) Plan

Dental insurance

Health insurance

Paid Life & AD &D Insurance

Paid Long Term Disability Insurance 

Paid time off

Vision insurance

MERIT CRO, Inc. is an equal opportunity employer, and we are committed to hiring a diverse and talented workforce. 

It is the employment policy and practice of MERIT CRO, Inc. to recruit and hire qualified employees without discrimination based on race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, national origin, ancestry, citizenship status, age, mental and physical disability, pregnancy, medical condition, genetic information, political affiliation, union membership, status as a parent, marital status, military or veteran status, or other classes protected by applicable law, and to not discriminate concerning compensation and opportunities for advancement, including upgrading, promotion, and transfers. We will provide reasonable accommodation to qualified individuals throughout the application, interviewing, and employment process. If you require reasonable accommodation, please contact us.