Urwah Admin

DM Clinical Research

<div>A Regulatory Specialist I works closely with our Clinical Research sites to ensure the integrity and accuracy of all 
regulatory documentation within the organization. 
DUTIES &amp; RESPONSIBILITIES<ul><li>
Prepares, facilitates, and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions</li><li>
Follows up, communicates, and facilitates responses to queries of the IRB, Sponsor, and other committee as a result of their review of submissions</li><li>
Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research</li><li>
Perform regulatory binder maintenance and quality control checks</li><li>
Participates in quality assurance (QA) and control programs related to the overall project and regulatory compliance</li><li>
Any other tasks as assigned by management</li></ul> 
KNOWLEDGE &amp; EXPERIENCE 
Education:<ul><li>
Associates degree, required</li><li>
Bachelor's degree, preferred</li></ul>
Experience:<ul><li>
FDA, IRB administration, research, and regulatory affairs familiarity</li><li>
12 months of clinical research experience</li></ul>
Credentials:<ul><li>
N/A</li></ul>
Knowledge and Skills:<ul><li>
Strong written and oral communication skills.</li><li>
Strong computer skills, including Microsoft Office, Excel, and PowerPoint.</li><li>
Ability to manage time-sensitive projects in order to meet deadlines.</li><li>
Strong ability to establish and maintain effective working relationships.</li></ul></div>

Regulatory Specialist I

<div>We are seeking a Product Manager (L3 Level, 7+ Years Experience) to define product vision, strategy, and roadmap, and for driving execution across cross-functional teams to deliver high-value products. This role acts as the voice of the customer while balancing business objectives, technical feasibility, and operational constraints. This role requires a strong mix of business acumen, technical understanding, and Agile methodology expertise to ensure successful product sprint delivery. 
 
DUTIES &amp; RESPONSIBILITIES<ul><li>
Define and communicate product vision, strategy, and roadmap aligned with business goals</li><li>
Identify market opportunities through customer research, analytics, and stakeholder input</li><li>
Translate strategic objectives into clear product initiatives and measurable outcomes</li><li>
Act as the primary liaison between business stakeholders, engineering, design, operations, and vendors</li><li>
Gather and prioritize requirements from internal and external customers</li><li>
Manage stakeholder expectations and communicate progress, risks, and trade-offs</li><li>
Own and maintain the product backlog, ensuring alignment with roadmap priorities</li><li>
Write clear product requirements, user stories, and acceptance criteria</li><li>
Partner with engineering to plan, execute, and deliver releases on time and within scope</li><li>
Define success metrics (KPIs) and monitor product performance post-launch</li><li>
Use data to inform prioritization, enhancements, and future roadmap decisions</li><li>
Drive continuous improvement through feedback loops and retrospectives</li><li>
Ensure products comply with regulatory, security, and privacy requirements</li><li>
Collaborate with legal, compliance, and risk teams as needed</li><li>
Work with the success team to write product documentation and adoption plan</li></ul>
KNOWLEDGE &amp; EXPERIENCE 
Education:<ul><li>
Bachelor&rsquo;s degree in business, Technology, Engineering, or related field</li></ul>
Experience:<ul><li>
3&ndash;7+ years of experience in product management or a related role</li><li>
 Strong understanding of Agile/Scrum methodologies</li><li>
Proven ability to manage complex, cross-functional initiatives</li></ul>
Credentials:<ul><li>
Certified Product Manager (CPM) (Desired)</li><li>
Scrum Master (Desired)</li></ul></div>

Product Manager

<div>The Clinical Trial Project Manager &ndash; Network Support is responsible for executing and supporting clinical trial activities across the full study lifecycle, from study start-up through maintenance and close-out, across multiple sites within the DM Clinical Research network.
This role functions as an execution-focused individual contributor supporting centralized network oversight. The Project Manager may be assigned to focus on specific lifecycle phases (e.g., study start-up, study maintenance, amendments, close-out) based on operational priorities, while maintaining familiarity with end-to-end trial workflows. 
DUTIES &amp; RESPONSIBILITIES
1. General Trial Lifecycle Support
a. Support assigned clinical trials across one or more lifecycle phases, including study start-up, active study maintenance, amendments, and study close-out.
b. Maintain accurate study-level trackers, timelines, and task lists to ensure visibility into study progress and deliverables.
c. Monitor assigned milestones and proactively flag risks, delays, or gaps to centralized oversight for guidance and resolution.
d. Coordinate with internal teams (Regulatory, Site Operations, Clinical Data, Contracts &amp; Budgets, Patient Engagement, etc.) to support timely and compliant trial execution.
e. Support documentation completeness, accuracy, and readiness in accordance with study requirements and organizational SOPs.
2. Study Start-Up (as assigned)
a. Track regulatory and contractual deliverables required for site activation.
b. Support IRB submissions, responses, and activation readiness activities.
c. Assist with amendment-related start-up activities as needed.
3. Study Maintenance (as assigned)
a. Support ongoing study activities post-activation, including:
i. Tracking visit readiness and milestone completion
ii. Monitoring protocol amendment implementation
iii. Supporting issue resolution tracking and follow-up
b. Assist with maintenance of essential documents and study-level compliance tracking
4. Study Close-Out (as assigned)
a. Support close-out activities, including documentation tracking, reconciliation support, and final deliverable coordination.
b. Assist with readiness tracking for study close-out milestones.
5. Reporting &amp; Communication
a. Prepare routine internal status updates and reports to support centralized oversight and decisionmaking.
b. Participate in internal meetings related to assigned trials as required.
c. Escalate risks and issues through established internal pathways. 
KNOWLEDGE &amp; EXPERIENCE
Education:<ul><li>
Bachelor&rsquo;s degree preferred.</li></ul>
Experience:<ul><li>
4&ndash;6 years of experience in clinical research or clinical trial operations</li><li>
Experience supporting multiple phases of the clinical trial lifecycle</li><li>
Experience working within a site network, SMO, CRO, or sponsor environment</li></ul>
Credentials:<ul><li>
Certification in Project Management, such as ACRP-PM, or a related qualification in the field.</li></ul>
Knowledge and Skills:<ul><li>
Working knowledge of U.S. clinical trial regulatory processes and GCP requirements</li><li>
Strong execution and organizational skills</li><li>
Ability to manage multiple studies and priorities in parallel</li><li>
Clear written and verbal communication skills</li><li>
Detail-oriented with strong follow-through</li><li>
Comfortable working in a fast-paced, changing operational environment</li><li>
Proficient with standard productivity tools (e.g., Microsoft Office, Google Workspace)</li></ul></div>

Clinical Trial Project Manager

<div>A Central Clinical Data Coordinator II works to coordinate and implement data collection for various studies, focusing on the day-to-day operations including, monitoring the completion of project-related tasks, maintaining study-related procedures to ensure protocol and regulatory compliance. 
 
DUTIES &amp; RESPONSIBILITIES<ul><li>
Transcribe and manage data for assigned clinical studies</li><li>
Maintain training &amp; working knowledge of current FDA GCP/ICH guidelines, organizational SOPs, guidance documents,work instructions, and study protocols.</li><li>
Ensure the quality and timeliness of data transcribed for assigned studies within appropriate reporting requirements.</li><li>
Contribute towards ensuring internal processes are in accordance study requirements</li><li>
Participate in training new Clinical Data team members.</li><li>
Resolve any discrepancies, queries and and other study-related abnormalities in-line with company and study protocols</li><li>
Complete eDiary functions</li><li>
Adequately document and report on clinical trial progress as per applicable requirements</li><li>
Contribute to, and/or generate requested reports for management</li><li>
Participate in trainings and meetings as required</li><li>
Submitting required administrative paperwork per company timelines</li><li>
Perform quality checks as required by Clinical Data management</li><li>
Any other matters as assigned by management pertinent to trial related functions.</li></ul> 
KNOWLEDGE &amp; EXPERIENCE 
 
Education:<ul><li>
Associate degree preferred</li><li>
Bachelor&rsquo;s Degree required</li></ul>
Experience:<ul><li>
Experience with medical terminology is a plus</li><li>
1+ years experience with clinical research is required</li></ul>
Credentials:<ul><li>
N/A</li></ul>
Knowledge and Skills:<ul><li>
Strong knowledge of Google Suite products, Clinical Databases and other computer-related software</li><li>
Excellent oral and written communication skills</li><li>
Excellent planning and organizational skills with effective time management &bull; Excellent interpersonal skills</li><li>
Meticulous, independent, and capable of working with minimal supervision</li><li>
Excellent data handling and analysis</li><li>
Problem-solving skills</li><li>
Thorough understanding of clinical research principles and processes. Ability to input into process initiatives, and procedures related to Good Clinical Practices (GCP).</li></ul></div>

Central Clinical Data Coordinator II

Join DM Clinical Research and explore 4   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

DM Clinical Research

ABOUT_COMPANY

Regulatory Specialist I

Product Manager

Clinical Trial Project Manager

Central Clinical Data Coordinator II