Job details

Monitoring Team Lead/Senior Monitoring Team Lead

The job details are as follows:

What We Do

We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.

How you’ll contribute
Plan, implement and execute Clinical Monitoring activities for assigned studies. Functionally responsible for study assigned Clinical Monitoring team members (central, field, contract and permanent staff), monitoring activities, and support of study sites to ensure compliance with United Therapeutics Corporation (UTC) process, applicable regulations and industry guidance throughout the duration of the trial. Establish study-specific documentation; inclusive of the Clinical Monitoring Plan detailing field and central monitoring activities and collaboration with cross functional members/vendors for data cleaning, monitoring visit report annotations and letters (confirmation/follow-up), visit agenda templates, training materials and site-specific training matrix. This position is based remotely with up to 20% travel.

Trial Duties/Responsibilities

Serve as the functional lead and Point of Contact (POC) for central and field Clinical Monitoring activities for assigned study(ies)
Define, implement, and ongoing measurement of expectations with the Clinical Monitoring team; inclusive of the Clinical Monitoring Plan, Enrollment/Recruitment Plan, On/Off site Data Cleaning Plan as a stand-alone or integrated in other study plans
Partner with cross functional team members to ensure the Clinical Monitoring team receive protocol, therapeutic and project-specific systems training
Develop tools to assist study-assigned Clinical Monitoring team with monitoring activities and processes such as annotated monitoring visit reports (MVRs), letters (confirmation/follow-up), visit agenda templates, checklists and spreadsheets.
Accountable for the clinical monitoring delivery for assigned study(ies)
Review and identify site trends (e.g. enrollment, data entry, query resolution, non-compliance, action items) and monitoring team performance (e.g. data cleaning, visit documentation compliance, visit frequency, action item closure, query aging) and proactively develop solutions
Review and approval of visit documentation for assigned study(ies) according to UTC SOPs
Support CRAs (central and field) with resolution of significant site issues; inclusive of Serious Adverse Event (SAE) reconciliation, non-compliance (deviations/violations), Action Items (AIs), and escalation of other issues
Coordinate central and field monitoring activities related to data cleaning within the EDC system and study-specific portals
Oversight of scheduling and management of monitoring visits throughout the duration of assigned study(ies); site management coordination activities
Serve as the owner for Clinical Monitoring documents required for the study(ies) electronic Trial Master File (eTMF) and ensure timely, quality, and complete filing
Provide feedback to Clinical Monitoring Management regarding CRA performance and/or cross functional team member Managers for performance appraisals, as requested
Serve as a mentor for Clinical Monitoring team and perform co-monitoring/training visits, as required
Conduct on-site visits, central data review, analytics review and/or site management, as needed, to support monitoring activities

Meeting Attendance and Discussions

Active participant in Clinical Monitoring department meetings
Attend develop and present content (as needed) for Investigator and Study Coordinator Meetings (In person or virtual)
Collaborate with cross functional team members to develop timelines and ensure adherence to milestones throughout the duration of the study(ies)
Active participant in Internal Team Meetings to provide updates concerning Clinical Monitoring activities for assigned study(ies)
Lead regularly scheduled Clinical Monitoring team teleconference meetings (including agenda development and distribution of meeting minutes)

Corporate, Therapeutic and Industry Training

Attend relevant conferences, scientific meetings and corporate offered training sessions, as required/necessary, to remain current on therapeutic areas under study for UTC products and industry practices
Identify/communicate lessons learned and implement best practices to promote ongoing improvement for assigned studies

Department Duties

Serve as a mentor to CRAs to develop best practices and ensure efficient/effective monitoring activities are applied across studies
Perform other duties as assigned

For this role you will need

Minimum Requirements

For Monitoring Team Lead level:

Bachelor’s degree in arts/sciences (BA/BS) in a biological or related life sciences; nursing qualifications or relevant clinical research experience in pharmaceutical/biotech/medical device or CRO industries may be considered
8+ years of experience working in pharmaceutical, biotech, medical device, or CRO industry with progressive experience working in clinical trials
6+ years of relevant monitoring experience
1+ years of Lead CRA experience

For Senior Monitoring Team Lead level:

Bachelor’s degree in arts/sciences (BA/BS) in a biological or related life sciences; nursing qualifications or relevant clinical research experience in pharmaceutical/biotech/medical device or CRO industries may be considered
10+ years of working in pharmaceutical/biotech/medical device or CRO industry with progressive experience working in clinical trials
8+ years of relevant monitoring experience
4+ years of oversight and management of clinical monitoring team at the study level

For both levels:

Competent end user of Microsoft Office suite (Outlook, Word, Excel, PowerPoint).
Demonstrated ability to work in clinical trial electronic systems including eTMF, EDC, IRT, CTMS, and other vendor portals (i.e., imaging, EKG, spirometry, lab, etc.)
Responsible for working within the established budgets for a given clinical project
Track personal finances for expense reporting and regular submission for payment
Ability to successfully perform all aspects of site management
Excellent understanding of relevant medical / therapeutic knowledge and medical terminology
Excellent understanding of Code of Federal Regulations (21 CRF Part 11, 50, 54, 56, 312, 812), Good Clinical Practices (GCP), ISO 14155 and clinical trial process
Strong interpersonal and written/oral communication skills; including ability to present topics/study material to an audience
Strong time management and organizational skills
Attention to detail and accuracy in work
Ability to multitask and prioritize in a rapidly moving environment

At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.

Applicable to Colorado Applicants Only:

The full salary range for the Monitoring Team Lead and Senior Monitoring Team Lead roles is $120,000 - $156,000.
This role is also eligible for the Company’s incentive plan
The Company also offers benefits as outlined to eligible employees:
https://www.unither.com/careers-benefits.html
The hourly or salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, seniority, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range is only applicable for jobs to be performed in Colorado. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities

United Therapeutics Glassdoor Company Review

3.2

United Therapeutics DE&I Review

No rating

CEO of United Therapeutics

Martine A. Rothblatt

Approve of CEO

By United Therapeutics

Develop the best medicines possible from our intellectual property. Conduct the most insightful clinical trials of our medicines. Achieve superior communication and awareness of our products among physicians. Grow our business to be in the top qui...

9 jobs

MATCH

Calculating your matching score...

FUNDING

Public

INDUSTRY

Biotech & Pharmaceuticals

TEAM SIZE

501-1000

LOCATION

Hybrid, based in Silver Spring, MD

DATE POSTED