Senior Manager, Clinical Monitoring (Remote - US)

California, US residentsclick here.

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

Manage and allocate assigned Clinical Monitoring staff (CRAs, iCRAs, MTLs) to ensure projects are appropriately resourced and employees are trained and meeting corporate and project objectives, timelines, deliverables and milestones.

Lead, coach, and motivate Clinical Monitoring staff to ensure adherence to department standards and facilitate training and oversight of department procedures.

Mentor and support junior Managers and Clinical Monitoring staff concerning career development and performance improvement.

Take ownership or collaborate on organizational improvement within Clinical Monitoring and the larger Clinical Operations organization of UTC.

This position is based remotely anywhere in the continental United States and has a travel expectation of up to 50%.

Department Duties / Responsibilities :

Regularly interact with senior management or executive levels regarding Clinical Monitoring functional area activities;

influence senior level leaders regarding matters of significance to United Therapeutics Corporation

• Propose, develop and implement plans, policies, guidelines, forms / templates and Standard Operating Procedures (SOPs) for Clinical Monitoring to Associate Director / Director
• Assist Associate Director / Director, Clinical Monitoring and Training Department to develop and administer an effective orientation / on-boarding process for new hire Clinical Monitoring staff
• Collaborate with Clinical Monitoring Management and / or cross functional departments in relevant process improvement initiatives;

may assist with the creation and delivery of new Clinical Monitoring Department initiatives; improvement plans or training

• Lead Clinical Monitoring team with resolution of findings from Clinical Quality Assurance audits and / or regulatory inspections
• Develop and maintain effective relationships with Clinical Operations Management team
• Collaborate with Clinical Monitoring Management members to ensure consistent oversight of Clinical Monitoring staff
• Coordinate and facilitate Clinical Monitoring Department Meetings; including the development / distribution of agendas and minutes, as required
• Serve as a mentor to Clinical Monitoring Managers / Associate Managers, and staff to develop best practices and ensure efficient / effective monitoring activities are applied across studies
• Serve as a Subject Matter Expert (SME) for systems / technology, development of new templates for Clinical Monitoring Department
• Assist Associate Director / Director, Clinical Monitoring with administration and forecast of functional area budget, timelines, and performance, assist with budget planning

Personnel Management Responsibilities :

Ensure productivity, quality, and consistency of direct reports performance through routine review of available metrics and communication with direct reports;

assist with resolution of performance issues / discussions escalated from junior Managers and ensure issues / performance discussions are escalated appropriately to the Associate Director / Director, Clinical Monitoring

• Complete and deliver performance assessments of direct reports
• Conduct routine one-on-one meetings with direct reports to discuss workload, performance, and provide feedback / recommendations
• Provide guidance and coaching to direct reports to increase competencies and career development growth
• Mentor junior managers on personnel management, as needed
• Manage leave requests and review / approve business expenses, as required
• Conduct assessments (onsite visit activities, in-house monitoring activities and monitoring lead function activities) of Clinical Monitoring staff

Corporate, Therapeutic, and Industry Training Responsibilities :

• 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 within Clinical Monitoring / Clinical Operations

Project Duties / Responsibilities :

• Represent Clinical Monitoring and interact with strategic partners on study teams for outsourced clinical studies
• Provide leadership and guidance on interactions with UTC Medical Science Liaisons (MSLs) to optimize relationship with investigational sites
• Serve as a point of escalation for Clinical Monitoring and / or staff performance issues for clinical studies
• Provide input into the feasibility and risk assessment (initial / ongoing) of clinical protocols
• Participate in networking activities with important institutions and investigators
• Build and maintain long-term professional relationships with clinical investigators
• Attend, contribute and / or present at Investigator Meetings, as necessary
• Conduct field / central monitoring and / or Monitoring Team Lead activities (e.g. on-site visits, central data review, analytics review, site management, or monitor visit documentation review) to support monitoring activities, as necessary
• Support the Monitoring Team Lead (MTL) or designee in the development of the monitoring / site and subject recruitment strategies;

review Clinical Monitoring Plan (CMP), as necessary

Perform other duties as required

For this role you will need

Minimum Requirements

• Bachelor’s Degree in biological sciences, nursing or related field
• 10+ years of experience as a Clinical Research Associate (CRA) / CRA Manager along with prior relevant experience in pharmaceutical / biotech / medical device or CRO industry with progressive experience working in clinical trials and
• 4+ years of relevant monitoring team / trial management experience and
• 4+ years of experience with resource / people management, conflict / resolution management, change management, and people motivation skills
• Demonstrated ability to effectively provide guidance and direction to others and demonstrate experience in clinical trial management, monitoring and developing study documentation (e.

g. operational plans, report / letter templates and annotations, and training materials for the monitoring team)

• Knowledge of the Code of Federal Regulations (CFR), International Conference on Harmonization (ICH) Guidelines, and Good Clinical Practices (GCP)
• Competent end user of UTC electronic systems (Phlex eTMF, Medrio / Oracle InForm / Medidata RAVE EDC, Clario CTMS)
• Understanding of the clinical research process; including working knowledge of clinical monitoring duties / responsibilities
• Ability to mentor and / or coach clinical staff; problem-solving abilities to assist others to resolve / recommend solutions to clinical monitoring issues
• Demonstrated leadership to support change management within the Clinical Monitoring function and / or collaborating with cross functional leaders for department changes
• Effective knowledge of resource management of Clinical Monitoring staff
• Demonstrated experience with CAPA Management
• Good written / oral communication skills; including ability to provide training and present topics / study or department materials to an audience
• Demonstrated leadership and good interpersonal abilities to establish and maintain effective working relationships with direct reports, coworkers, vendors, and senior management
• Competent end user of Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, TEAMs)

Preferred Qualifications

• 1+ year of previous experience with all phases of clinical research
• Knowledge of relevant medical / therapeutic areas for UTC and understanding medical terminology
• Effective time management and organizational skills to manage competing priorities

The salary for this position ranges from $150,000 to $187,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.