Clinical Study Manager

Proclinical is currently recruiting for a remote Clinical Study Manager for a global biotechnology company. As the Clinical Trials Manager, you will be responsible for the day-to-day activities associated with managing clinical studies. This is a 6-month contract position working closely with the Associate Director, Clinical Operations and collaborating with colleagues in other functions. The Clinical Trials Manager supports the operational team to ensure excellent operational oversight of clinical studies. The Clinical Trials Manager contributes to and manages the project plans, manages and oversight of vendors, performs tasks during protocol design to final CSR, to produce high-quality study data, adherence to Good Clinical Practice and to achieve corporate goals on time and on budget.

Job Responsibilities:

• Manages clinical studies, including vendor management and oversight including CROs, IRB, DSMB and CRAs as needed.
• Organize and participate in investigational meetings and site training.
• Coach and mentor all staff under him/her; set objectives, solicit 360° feedback from stakeholders and conduct performance reviews to foster growth of staff.
• Ensure all necessary training is provided to his/her staff to support job performance and knowledge; remain cognizant of, and remove, any barriers or obstacles that impede his/her staff from achieving objectives.
• Participate in study start-up activities including protocol authoring, database design, study manuals, essential documents etc. with the mindset of "start with the end in mind" to ensure the operational team is poised for successful data to enable the program strategy.
• Oversee site selection, patient recruitment and retention.
• Author documents necessary for study initiation and execution; ensure other documents and manuals are provided for study initiation and execution.
• Interact effectively with Sr. Management within clinical operations and cross functional areas to provide updates and communicate issues.
• Manage drug supply needs by communicating with the relevant IVRS vendor, study sites
• Work closely with Translational Sciences to ensure timely and appropriate shipping of samples.
• Communicate regularly with Data Management to ensure data are being cleaned and coded appropriately and in a timely fashion.
• Interface with other team members, including Clinical Research Associates, to be aware of issues at sites that require attention.

Skills and Requirements:

• BS or BA required; MS in the biological sciences (e.g. Biochemistry, Pharmacology) preferred; PMP certification highly desired
• Minimum of 5-8 years of experience managing clinical studies in a pharmaceutical or biotechnology setting; At least 1 year of clinical monitoring experience or equivalent is desirable.
• Managing orphan drug disease trials is desired
• Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs
• Solid scientific background; able to understand biomarkers and clinical endpoints

Compensation

• A competitive compensation package will be presented to the right individual including base salary, bonus, and equity or indicated in the Employment Contract.

If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 267-297-3376 or m.jacobs@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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