Top 42 Clinical trial manager Jobs in Rockville Md

Clinical Compliance/Inspection Readiness, Manager - Clinical Operations
Immunocore —Gaithersburg, MD
- $107,250 - $178,750 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Bachelor of Science
Senior Clinical Data Manager
Supernus Pharmaceuticals Inc —Rockville, MD
- $145,000 - $160,000 a year
- Nursing
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
Clinical Data Manager
Ambu —Columbia, MD
- Full-time
- Remote
- Nursing
- Bachelor's degree
- Continuous improvement
Clinical Research Manager
The Geneva Foundation —Bethesda, MD
- $105,000 - $120,000 a year
- Full-time
- Vital signs
- Computer literacy
- Mid-level
Quick Apply
Senior Global Clinical Study Manager
IQVIA —Rockville, MD
- $93,100 - $232,800 a year
- Full-time
- Remote
- Bachelor's degree
- Continuous improvement
- Mentoring
- Work from home
Sr. TMF Manager
MacroGenics, Inc. —Rockville, MD
- $144,300 - $220,000 a year
- Remote
- 7 years
- Computer Science
- Bachelor's degree
- Paid parental leave
- Employee stock purchase plan
Quick Apply
5d
Senior Manager, Clinical Data Standards
Immunocore —Gaithersburg, MD
- $121,500 - $202,500 a year
- Full-time
- Computer Science
- Master's degree
- SQL
Manager / Sr. Manager, Clinical Operations - FSP West Region
Thermo Fisher Scientific —Washington, DC
- $115,000 - $178,000 a year
- Full-time
- Remote
- English
- Business development
- Travel
- Commuter assistance
- Paid parental leave
5d
Project Manager (Public Health)
Ripple Effect —Rockville, MD
- $118,168 - $135,894 a year
- Full-time
- Master's degree
- Business development
- Supervising experience
Quick Apply
13d
Clinical Research Regional Manager
ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATES PC —Rockville, MD
- Clinic
- Bachelor's degree
- Travel
Quick Apply
1d
Associate Account Manager - Clinical Trial Division - West Coast, US
Thermo Fisher Scientific —Washington, DC
- $76,700 - $115,025 a year
- Online Application
- Hybrid work
- Research
- Mid-level
- Master's degree
- Commuter assistance
- Paid parental leave
6d
Clinical Trial & Pharmacovigilance Manager
VENESCO, LLC —Falls Church, VA
- Full-time
- Medicine
- Management
- Databases
Quick Apply
Clinical Program Manager
Guidehouse —Bethesda, MD
- $85,000 - $141,000 a year
- Full-time
- Nursing
- Master's degree
- Databases
- Commuter assistance
- Health savings account
Clinical Program Manager
GAP SOLUTIONS INC —Bethesda, MD
- $125,000 - $185,000 a year
- Email
- Nursing
- Writing skills
- Master's degree
Quick Apply
Clinical Operations Manager DMID
Veritas Management Group, Inc. —Rockville, MD
- Full-time
- 7 years
- Mid-level
- Office
Quick Apply
10d
Manager, Research Management Office
Henry M. Jackson Foundation —Bethesda, MD
- $77,600 - $110,000 a year
- Full-time
- Hybrid work
- Senior level
- Health insurance
- Dental insurance
Medical Support Program Manager
Terrestris Global Solutions —Bethesda, MD
- $80,000 - $90,000 a year
- Full-time
- Mid-level
- High school diploma or GED
- Team management
- Tuition reimbursement
- Retirement plan
Quick Apply
Clinical Manager/Program Data Manager
Maryland Family Resource —Hyattsville, MD
- $80,000 - $95,000 a year
- Full-time
- Hybrid work
- Background check
- School experience
- Spanish
- Continuing education credits
- Health insurance
Quick Apply
Mental Health Patient Recruitment Specialist Lead
CenExel Clinical Research —Gaithersburg, MD
- $55,000 - $60,000 a year
- Full-time
- Background check
- Psychiatry
- Writing skills
- Health savings account
- Health insurance
Quick Apply
Scientific Outreach/Partnerships Manager - NIH
Global Solutions Network Inc —Rockville, MD
- $53.00 - $64.81 an hour
- Full-time
- Mid-level
- Databases
- Bachelor's degree
- Travel reimbursement
- Profit sharing
Quick Apply
8d

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Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

Immunocore -
Gaithersburg, MD

Apply Now

Job Details

Full-time
$107,250 - $178,750 a year

Qualifications

Clinical research audit management
Writing skills
Presentations for conferences or internal meetings
Clinical audit and monitoring
ICH guidelines
Clinical quality assurance standards
Cross-functional collaboration
Audit support

Full Job Description

Vacancy No

VN514

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA

Department

Clinical Operations

Key Responsibilities

This is an onsite position and can be located at either our Gaithersburg, MD or Conshohocken, PA sites.

The Clinical Compliance/Inspection Readiness, Manager is responsible for the management and execution of activities associated with inspection preparedness, inspection support, clinical procedural development and maintenance, clinical training programs, and assessment and investigation of clinical quality compliance issues. This onsite position can be located at either our Gaithersburg, MD or Conshohocken, PA sites.

KEY RESPONSIBILITIES

Lead the development and delivery of GCP and Inspection Readiness training for the Clinical o organization

Lead the development and implementation of processes and tools to support teams and functions in being inspection ready

Provide ongoing inspection readiness support and expertise to study teams, including risk mitigation and monitoring

Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections, including support of ongoing storyboarding

Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities

Coordinate follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)

Generate, analyze and communicate inspection readiness metrics

Drive continuous improvement into inspection readiness and inspection conduct support

Lead the development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates in compliance with global regulatory standards

Lead the strategy execution for role-based curriculum and GCP training within the Clinical organization

Collaborate with QA with the preparation/collection of all training documents in preparation for internal training file audit (e.g., completed SOP matrices, CVs, JDs etc.)

Assist with oversight and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments in collaboration with Quality Assurance

Assist with management and oversight of the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and

closure

Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.

Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)

Track status of open Quality Issues and CAPAs and coordinate with Clinical stakeholders to ensure timely and adequate closure, as appropriate

Generate, report, and respond accordingly to compliance/inspection readiness KPIs

OTHER DUTIES

Support and prepare internal and external clinical operations teams for audits

Provide training on Clinical Standard Operating Procedures and Work Instructions to ensure compliance with regulatory organizations.

Support and manage in collaboration with Quality Assurance the clinical quality database observations

Identify opportunities and provide leadership in continuous improvement of good clinical practices.

Establish and assure adherence to budgets, schedules, work plans, and performance requirements, relative to inspection readiness support and clinical compliance activities.

Regularly communicate with senior management or executive levels on matters regarding several functional areas

Experience & knowledge
Essential

At least 8 years relevant experience in a biotechnology/pharmaceutical industry and/or contract research organization (CRO) with experience in compliance, quality, training or related clinical operations function.

Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP.

Ensure an enthusiastic and open attitude towards continuous professional development

Experience with the following skill set:

o Performing PAI and Inspection readiness assessments
o Making high level presentations, both orally and in writing using organizational skills to
complement this
o Delivering open and honest constructive (positive and/or negative) feedback pertaining to
work in hand
oTaking responsibility and ownership for entrusted tasks; seeing tasks through to completion
and dealing with the consequences of failure or success.
o Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities.
Handling disjointed tasks effectively. in a highly collaborative, multi-disciplinary team setting.
o Being able to work productively with others to achieve tasks while showing consideration
for the needs and feelings of others.
o Accomplishing goals under project timelines.

Desirable
Prior experience with the following would be an advantage

Clinical auditing and relevant clinical operations functions

Compliance and training

Education & qualifications

BA / BS. or higher in science related field (biological science, medical, pharmacy or other health related discipline)

8+ years’ experience in related area with some experience in QA/Audit setting preferred

Clinical Operations and/or Inspection Readiness experience preferred

Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)

Some international and local travel maybe required. Approximately up to 20 % travel.

$107,250-$178,750

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

Apply Now

Refine Your Search

clinical trial manager jobs in rockville md

Clinical Compliance/Inspection Readiness, Manager - Clinical Operations

Senior Clinical Data Manager

Clinical Data Manager

Clinical Research Manager

Senior Global Clinical Study Manager

Sr. TMF Manager

Senior Manager, Clinical Data Standards

Manager / Sr. Manager, Clinical Operations - FSP West Region

Project Manager (Public Health)

Clinical Research Regional Manager

Associate Account Manager - Clinical Trial Division - West Coast, US

Clinical Trial & Pharmacovigilance Manager

Clinical Program Manager

Clinical Program Manager

Clinical Operations Manager DMID

Manager, Research Management Office

Medical Support Program Manager

Clinical Manager/Program Data Manager

Mental Health Patient Recruitment Specialist Lead

Scientific Outreach/Partnerships Manager - NIH

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