Project Manager

JOB SUMMARY(Brief statement summarizing main functions and purpose of the job):

Manages assigned clinical studies and serve as direct contact with DIRC’s clients and study auditors. Responsible for study setup, execution and archival (i.e., start-to-finish oversight). Provides ongoing direction to DIRC staff in the performance of study-related tasks, delegates study-related tasks to the appropriate staff, and resolves any problems/issues specific to assigned studies. Forms and maintains favorable working relationships with DIRC clients, and serves as the principal point of contact for sponsors/clients on assigned studies. Performs a variety of supervisory functions for DIRC staff under minimal supervision of the Director.

DUTIES AND RESPONSIBILITIES (List major functions in order of responsibility):

1. Executes and/or oversees all study startup activities for studies assigned, including but not limited to: (Percent of Time: 60%)

a. Performing independent research as needed in the planning / implementation of a study such that that the study activities ultimately: (1) support the ultimate goals of the sponsor and contract, (2) comply with all regulatory and policy requirements, (3) ensure the highest level of quality in the study data, and (4) promote efficiency, to maximize revenue potential for DIRC contracts.

b. Attending client planning meetings to understand the client’s needs with respect to the study details and conduct;

c. Reviewing the clinical protocol & contract/scope of work to understand the required services;

d. Creating a project startup plan and timeline that fulfills the task and schedule needs of the contract;

e. Developing an IRB proposal and following up on related IRB communications up to the point of approval;

f. Assigning and supervising DIRC staff for studies;

g. Communicating study requirements to DIRC staff and engaging in a variety of activities geared toward training the staff (such as holding project meetings and training sessions); ensuring that DIRC staff are adequately trained on the study and that the required personnel training documents are entered into the DIRC personnel record prior to study startup;

h. On an ongoing basis, acquiring new technical knowledge and skills necessary to write study procedures and materials supporting the latest technologies, including:

i. Designing, writing and modifying imaging protocols for novel / updated imaging technologies;

ii. Designing, writing and modifying grading protocols for new grading methods; and

iii. Designing and developing complex grading worksheets and CRFs for data collection.

i. Developing the project-specific manual of procedures;

j. Supervising the shipment of supplies and instructions to clinical sites;

k. Advising and assisting clinical sites with reading center procedures; and

l. Setting up billing parameters, methods and timing to ensure timely and correct billing for each study, accounting for the needs/complexities of different contracts.

2. Executes all ongoing study management activities, including but not limited to: (Percent of Time: 30%)

a. Supervision of the study staff in the activity of evaluating/qualifying sites for study participation;

b. Supervision of the study staff in the activities of receiving, verifying and logging of imaging materials received at the DIRC;

c. Periodically monitoring the flow of assigned-study materials through the grading process and working with the Operations Manager to ensure that reporting turnaround times are met;

d. Resolving problems with clinical sites;

e. Responding to client requests and participating in progress/planning meetings with clients;

f. Conducting client audits pertaining to assigned studies;

g. Entering billing information into the DIRC database; and

h. Generating/reviewing client invoices.

3. Oversees the documentation of the study and the ultimate archival of study materials. Consistently follows DIRC’s Standard Operating Procedures in documenting the study (including the implementation / documentation of photographic protocols, grading protocols, project-specific manual of procedures, study binder, grading worksheets and/or report forms, and any other materials necessary to document study activities and results of image grading). (Percent of Time: 5%)

4. Performs other projects as assigned by DIRC Director (Operations) or Medical Director, in support of the overall goals of the DIRC. (Percent of Time: 5%)

5. In collaboration with the Director, performs supervisory duties for DIRC staff assigned to studies including: overseeing work, productivity, and work schedules; reviewing timesheets; recruiting; and disciplinary action. (Percent of Time: Ongoing)

6. Responsible for the overall success of each assigned study and for the achievement of DIRC’s client service goals.

(Percent of Time: Ongoing)

7. Displays a positive client-service attitude and responds in a timely manner to client requests. (Percent of Time: Ongoing)

8. Responds to inquiries and requests for information requiring knowledge of departmental policies and procedures. (Percent of Time: Ongoing)

9. Perform all tasks in a safe manner in compliance with company safety policies and according to applicable regulations; maintains a neat workstation and environment. (Percent of time: Ongoing)

10. Display courtesy and consideration to patients, guests, physicians and staff. (Percent of time: Ongoing)

11. Maintain confidentiality of all records and information that pertains to patients, physicians, employees, the organization and in related interests. (Percent of time: Ongoing)

12. Perform special projects or other related work as required or requested. (Percent of time: Ongoing)

SUPERVISION:

Functions independently under minimal supervision of the Director of Operations, DIRC. Directly or indirectly supervises staff of studies assigned.

EDUCATIONAL EXPERIENCE, TRAINING (including Licenses and Professional Activities):

Required Experience/Training/Skills:

o Bachelor’s degree required.

o 5 years project management experience

o 1-2 years experience in the administration or coordination of clinical research

o Prior supervisory experience preferred.

o Above-average writing and editing skills

o High level of proficiency in Microsoft Word; minimum of intermediate proficiency for Excel, Outlook

o Superb critical thinking skills

o Above-average organizational skills

o Excellent client service attitude

o Excellent communication skills

o Able to work independently with minimal or no supervision

Preferred Experience/Training:

o Understanding of ophthalmology research helpful

o Experience with supervision and task delegation helpful

Job Type: Full-time

Pay: $65,000.00 - $75,000.00 per year

Benefits:

• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

People with a criminal record are encouraged to apply

Education:

• Bachelor's (Preferred)

Experience:

• Project Management: 2 years (Preferred)

Work Location: Remote