Associate Director of Project Management (US Remote) at MERIT CRO Inc

Madison, Wisconsin, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Aug, 26

Salary

0.0

Posted On

15 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Clinical Trial Management, Vendor Management, Regulatory Documentation, GCP Compliance, Staff Supervision, Training Development, Quality Control, Technical Support, Imaging Workflow, Data Reconciliation, Interpersonal Skills, Organizational Skills, Microsoft Office, Customer Support, Budgeting and Resource Allocation

Industry

Biotechnology Research

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 Associate Director of Project Management to oversees daily operations of the project management group and accurately and competently administers activities regarding assigned studies. Responsible for overseeing all study activities including: study start up; training activities; creating and distributing study documents; vendor management; regulatory documentation; maintaining study files; coordination of site correspondence and activities; and the end of study activities including document archival. Primary functions include overseeing the team of Project Managers performing activities associated with management of clinical trials including; monitoring data review and quality control functions; providing training and support for clinical sites, reading centers, and clients using EXCELSIOR™; ensuring study compliance for the lifecycle of a project. Additionally, this position leads departmental quality initiatives and ensures that projects/department milestones/goals are met and adhers to MERIT and/or study specific procedures and Good Clinical Practices (GCP). ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.) Administrative Duties: * Supervise Project Management personnel * Develop/implement training programs * Participate in development, recommendations and administration of project management standard operating procedures * Interview and contribute to final hiring decision of new PM staff * Monitor workload across projects and ensure appropriate coverage * Communicate project support needs to upper management * Monitor employee performance and routinely provide constructive feedback and coaching * Manage corrective, disciplinary, or termination activities including notification to Executive Team and Human Resources. * Act as a resource for other Project Management team members and provides guidance for project related inquiries. Study-Related Duties: * Monitor study start up activities * Monitor development and review EXCELSIOR™ configuration * Participate and lead project specific meetings and communications with sponsors, clinical sites and CROs * Develop and provide study specific training for reading centers and Project Management team members * Provide training and guidance for sponsor and CRO personnel with access to projects in EXCELSIOR™ * Participate and/or assign representatives for client and sponsor meetings * May serve as project manager for studies * Technical Support * Provide ongoing technical and imaging support to clinical sites, reading centers and sponsor/CRO personnel * Review and respond to customer support and complaint tickets in the helpdesk application * Provide expertise related to imaging equipment and services * Collaborate with internal IT support for qualification and validation of COTS applications * Imaging Workflow * Monitor image receipt for multiple projects to meet sponsor expectations for turnaround times and quality review * Monitor development and approval of procedures for image processing and data quality review * Manage study queries and problematic data submissions * Work with the Imaging team to identify study needs and develop materials to support those working on studies * Project close out activities * Monitor Data reconciliation activities * Monitor turnaround times for data lock activities * Coordinate with reading center personnel 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 * Provide guidance and training to sponsors, CROs and clinical sites on the use of EXCELSIOR™, including software functionality and technical support * Ensure the internal team is appropriately trained in the use of EXCELSIOR™, and if required, provide additional training support and development * Review, categorize, and respond to customer support and complaint tickets in the helpdesk application 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. 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 (or internal work experience). A minimum of five (5) years of clinical trial or project management experience in a related field. Experience in clinical trial project management with another company/organization within the industry is preferred, but not required. 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 leader. 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: 401(k) Dental insurance Disability insurance Health insurance Life 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.

Responsibilities

Oversees the daily operations of the project management group and manages the full lifecycle of clinical trial activities. Leads departmental quality initiatives and supervises project management personnel to ensure study compliance and goal attainment.