Clinical Trial Manager

Great long term contract opportunity for a Clinical Trial Manager with a local pharmaceutical company in Waltham MA. Looking for 5+ years clinical research experience in a pharmaceutical/biotech, CRO setting. Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials. Will be responsible for the oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I

-

IV of development.

BS or healthcare degree required; Masters preferred.

First Shift hybrid opportunity requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. Travel domestic and international - up to 25%.

Clinical project team member works closely with the Sr CTM and/or Clinical Program Manager and is responsible for oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables.

Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and contract & budget negotiations.

Participates in CRO and other vendor selection along with CPM and Director Clinical Outsourcing

Oversees and works directly with CROs, vendors, field monitors and other partners.

Establishes relationships with investigators, study coordinators, site personnel and other external key stakeholders.

Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation, accruals, and re - forecasting, with Clinical Outsourcing, Finance and Project Management

Responsible for study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.

Works with Patient Recruitment department and is responsible for overall recruitment strategy, enrollment projections, and meeting established targets.

Coordinates and/or participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents.

Leads and participates in internal cross - functional clinical team meetings; serves as main point of contact for study - level status updates.

Presents at clinical team meetings and other forums on study progress.

Works with Study Start - up and coordinates study start - up activities including feasibility, investigational product and materials preparation, trial master file set -

up, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments.

Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors.

Participates in SOP development, process mapping, training of junior CTMs and CTAs, and other departmental activities.

Direct line management and supervision of CTAs

Responsible for performance reviews and supporting professional development for direct reports.

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About Advantage Technical
With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit .

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors.

We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer.

This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.

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