Clinical Trial Program Manager

How many people can answer the question, "What do you do for a living?" with the answer, "I help find cures for cancer." At Blood Cancer United, employees take our mission seriously. Whether you work in one of our regions, are an accountant at the national office or a specialist in our Information Resource Center, you work each day on making our bold goal a reality: to enable patients with blood cancer to gain more than one million years of life by 2040. Join us and give new meaning to the word, "job."
Overview: The PedAL Clinical Trial Manager (CTM) serves as the primary liaison between Blood Cancer United and the Pharmaceutical Clinical Research team, overseeing the successful execution of clinical trials from inception to completion. This role bridges the gap between scientific and operational aspects of clinical research, ensuring projects are carried out efficiently, within budget, and in compliance with regulatory standards. The CTM is responsible for leading cross-functional teams to deliver high quality clinical trials that evaluate the safety and effectiveness of pharmaceuticals.

Key Responsibilities:Trial Planning and Initiation:

• Support bidding and defense conversations to win clinical trials. Consult with Contract Research Organizations (CROs) on bid strategies, including sites, patient enrollment, and overarching approaches.
• Manage and help finalize scope conversations leading to clinical trial contracts.
• Contribute to the review and finalization of trial protocols and related documents.
• Establish and maintain successful collaborations with customers, CROs, third-party vendors, study investigators, and site research personnel.
• Create comprehensive project plans (e.g., using SmartSheet, Excel, or other software) and build realistic timelines.
• Assess and recommend study vendors.

Trial Execution and Management

• Establish and maintain Blood Cancer United study file to ensure that key study documents are accessible when needed.
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
• Proactively identify potential delays and out-of-scope work.
• Implement proactive and reactive study challenge mitigations to keep trials on track.
• Participate in proactive identification, assessment, and management of clinical study risks.
• Identify issues and communicate and/or escalate to the appropriate leadership channels
• Provide study updates and report on study metrics to study governance committees
• Facilitate strategic decisions to optimize implementation of projects specific to the management of scope, financials, and schedules.
• Ensure that records of study activity, including case report forms, drug dispensation records, and regulatory forms, are maintained.
• Motivate team members and investigators toward trial goals.
• Ensure all study communication and documentation is filed in the Trial Master File.

Stakeholder Management

• Maintain constant communication with pharmaceutical partners to ensure client satisfaction and study team improvement.
• Conduct regular status meetings with internal teams and external partners.
• Develop budgets and additional timelines that are realistic yet aggressive.
• Prepare and deliver periodic updates to BCU leadership and other internal stakeholders.
• Collaborate on an as-needed basis with the BCU Communications and Constituent Experience teams to develop promotional materials, internal communications, and provide input on website content.

Quality and Compliance

• Ensure the clinical project team maintains a continuous state of audit readiness.
• Assure compliance with all applicable ICH/GCP, FTC, and FDA regulations, IRB/IEC parameters, and SOPs.
• Anticipate project risks and develop mitigation strategies/plans to address complex risk factors.
• Review clinical monitoring reports, including Site Initiation Visit reports, Interim Monitoring Visit reports, and Close Out Visit reports.
• Support development and maintenance of internal and external clinical study materials, processes, manuals, plans, committees, and other necessary documents.

#LI-Remote

Qualifications:Education and Experience:

• Bachelor's degree in life sciences, nursing, pharmacy, medical sciences, or related field preferred.
• 5+ years of clinical research experience (e.g., pharmaceutical, medical device, IVD, biotechnology, CRO), including proven ability to oversee clinical teams in the conduct of multicenter, complex studies. Oncology experience highly preferred.
• Certifications such as Certified Clinical Project Manager (CCPM) or Project Management Professional (PMP) are preferred.

Required Skills and Competencies:

• Knowledge of clinical trial concepts and practices, including clinical research guidelines.
• Knowledge and understanding of project management standards used to develop and maintain integrated project plans.
• Strong attention to detail and strong organizational skills.
• Ability to track multiple deadlines and budgets.
• Team leadership and collaboration abilities.
• Excellent communication and interpersonal skills.
• Problem-solving and decision-making skills.
• Proven ability to work effectively and independently with multi-level teams.
• Ability to manage multiple projects in a fast-paced and changing environment.
• Demonstrated and effective interpersonal, communications, and negotiation skills for a wide variety of audiences.

Employee Value Proposition:
As a valued member of Blood Cancer United, you are eligible for a comprehensive benefits package. Our offerings include medical, dental, and vision insurance; life insurance; flexible spending accounts; a 403b retirement plan along with generous paid time off. In addition, we observe federal paid holidays throughout the year, and offer a wellness program and an employee assistance program.

We are excited to share the base pay range for this position is $111K to $120K. The offered compensation may vary based on factors such as geographic location, business need, market conditions, proficiencies, skills, education, and experience. Additionally, at Blood Cancer United we place a high value on internal pay equity and will consider the current compensation of similarly situated roles and direct team members. Base compensation is only one component of our Total Rewards program, which also includes an annual incentive plan and a competitive benefits package.
The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of employees. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Disclaimer
Blood Cancer United is an equal employment opportunity employer committed to diversity and inclusion in its workplace. All qualified applicants will receive consideration for employment without regard to sex, gender, gender identity and expression (including transgender status), sexual orientation, pregnancy, age, race, color, creed, national origin/ancestry, citizenship, religion, genetic predisposition or information, physical or veteran status, or any other characteristic protected by law. Blood Cancer United seeks such skilled and qualified individuals to share our mission and where they will join a cohort of others who have chosen to call Blood Cancer United home. Blood Cancer United complies with all applicable laws which prohibit discrimination and harassment in the workplace, and is committed to maintaining a diverse and inclusive environment supportive of all of our employees and the communities we serve.