Feasibility and Study Start-Up Manager

Feasibility and Study Start-Up Manager Conquest Research Winter Park, FL Job Details Full-time $75,000 - $90,000 a year 3 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Vision insurance 401(k) matching Life insurance Qualifications Customer communication Operations management Interpersonal skills Bachelor's degree Team management Attention to detail Organizational skills Microsoft Teams Clinical trials Productivity software Task assignment Time management Analytics Full Job Description

JOB SUMMARY

The Study Start-Up Manager is responsible for working with customers and internal teams to operationalize and streamline the study start-up process across the network. This role will oversee and manage the full start-up cycle, from feasibility to study award to site activation. The Study Start-Up Manager will also promote Conquest Research as a priority site network to participate in clinical research studies to a diverse set of current and prospective sponsors and CROs.

RESPONSIBILITIES

Collaborate closely with Business Development, utilizing study pipeline tracker (or CRM) to manage data and provide up-to-date communication on feasibility status Support site network feasibility activities including completion and submission of Feasibility Questionnaires (FQs) Requires adequate knowledge of each site's relevant experience, capabilities, equipment, etc. To be completed in conjunction with CEO & clinical staff Assist with PSV scheduling, preparation, and completion in local market and ensure adequate follow-up throughout site selection process Oversee and provide assistance for PSV(s) being conducted in other regions Identify and resolve issues during the pre-award process, escalating complex challenges as necessary Coordinate all clinical trial start-up activities prior to site activation Collaborate with all staff members involved in the study (e.g.- Regulatory, B&C, Lead CRCs, study-specific lead CRC, Investigators, lab staff, pharmacy staff, EDC staff, QA/QC, etc.) to ensure that start-up activities are on track and in accordance with client and internal expectations Communicate with external vendors including CROs, sponsors and monitors on behalf of clinical/operational staff Prepare for and host biweekly interdepartmental meetings to review all studies in start-up. Monitor and track interdepartmental progress throughout study start-up cycle on the Master Study Start-Up Tracker Monitor status updates in CTMS Start-Up Checklist Oversee and participate in formal pre-SIV training of study staff Analyze and maintain study start-up data (metrics), ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement Represent the company and present a professional image to customers to supply an outstanding image and impression of the company Perform other duties as assigned

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

Excellent verbal and written communication skills Excellent interpersonal and networking skills Excellent sales and customer service skills Excellent organizational skills and attention to detail Excellent time management skills with a proven ability to meet deadlines Strong analytical and problem-solving skills Strong presentation skills Ability to prioritize tasks and to delegate them when appropriate Ability to function well in a high-paced and at times stressful environment Self-motivated and able to work independently Clinical trial experience

MINIMUM REQUIRED EDUCATION, EXPERIENCE, AND CERITIFICATIONS

Bachelor's degree or equivalent/applicable experience required 3+ years of clinical research experience, with preference given to those with clinical trials and logistics experience and a clinical background and/or having worked in a CRO, sponsor or a similar service environment Microsoft Office, specifically Teams with preference for experience in Salesforce or other CRM Clinical trial experience is a requirement

PREFERRED QUALIFICATIONS

Answering inquiries and providing information about the company's services Obtaining and facilitating the completion of Feasibility Questionnaires Maintaining accurate and up-to-date information in the company's CRM or equivalent system Meeting or exceeding study award targets and goals Retrieve relevant information from protocol to present to clinical team(s) Filter studies to appropriate PI based on indication Collaborate with clinical operations team regarding new trial opportunities Liaison of necessary awarded trial information to Regulatory, Contracts and Clinical team(s) Provide weekly/biweekly activity updates to management team Develop a strong understanding of site network capabilities to present to potential sponsors and leads

Pay:

$75,000.00 - $90,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Vision insurance

Education:

Bachelor's (Required)

Experience:

Clinical Trial:

3 years (Required)

Work Location:

In person