Clinical Operations Senior Manager or Manager - Rare Disease Clinical Trial Services

Location: New York, New York US

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Job Id: 1501

Position Title: Senior Manager, Clinical Operations & Manager, Clinical Operations

External Description:

Precision for Medicine Oncology & Rare Disease is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

About You:

  • You don’t like to just sit back and have decisions made for you.
  • You follow your instincts and actively make decisions that help move projects along to completion.
  • You are an excellent communicator and want your voice to be heard in order to impact change.
  • You aren’t afraid to take ownership of a project and look forward to seeing it thrive.
  • You’re a teammate who doesn’t mind stepping outside of your job description to make sure our company and client goals are met and exceeded.
  • You are passionate about finding cures for those suffering from debilitating and rare diseases.

We are offering you the opportunity to plan and execute the clinical research operations of a clinical trial; recording and reporting studies accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable standards.

We empower our teammates to be the change they wish to see for patient care.

What you can expect day to day:

  • Key responsibility for the clinical and site management aspects of assigned studies. Serving as the primary liaison with Client representatives as well as internal personnel in the Project Management, Data Management, Medical and Safety, and Biostatistics departments to ensure the timely initiation and completion of clinical trials.
  • Handling the clinical budget throughout the duration of the project and assists in the development of out of scope documentation and costs.
  • Developing and maintaining study plans, guidelines, study trackers and tools. Tracking and reviewing monitoring reports.
  • Providing input regarding Clinical Operations for proposals, budgets and contracts; participates in bid defense meetings.
  • Writing and updating of SOPs as needed.
  • Manage employees and/or contractors within the Clinical department.
  • Leading or contributing to departmental process development.
  • Project forecasting and assigning resourcing through a combination of internal and external resources, as needed.

Qualifications:

Minimum Required:

  • Bachelor’s degree in a life science or related discipline of study or equivalent combination of studies, nursing qualifications, and/or work experience.

Other Required:

  • Manager level: 5+ years relevant experience to include proven ability to provide mentorship and direction to others effectively
  • Senior Manager level: 8+ year’s relevant experience, inclusive of 1-2 years directly managing others
  • Independent field monitoring experience
  • Clinical team lead or comparable supervisory experience
  • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
  • Solid interpersonal and organizational skills, attention to detail, and a customer service demeanor

Division: Precision For Medicine

Business Unit: Oncology & Rare Disease

Office Based: Carlsbad - 6005 Hidden Valley Road, Suite 170, Carlsbad, CA 92011

Employment Type: Exempt

Employment Status: Regular Full-time

Work From Home Available: Yes

City: New York

Country: United States

State: New York

Community / Marketing Title: Clinical Operations Senior Manager or Manager - Rare Disease Clinical Trial Services

Company Profile:

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

EEO Employer Verbiage:

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2018 Precision Medicine Group, LLC

Location_formattedLocationLong: New York, New York US

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

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© 2019 Precision Medicine Group, LLC. All rights reserved