Sr. Clinical Research Associate – Boston

Company Information:

Breakthrough Careers!
A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Position Summary:

We seek an energetic and results oriented professional to join our inflammation clinical operations team.

Duties and Responsibilities:

Manage all clinical operations from on-site monitoring and study management within a matrix environment.

Convene and lead a cross functional clinical team.

Plan, convene run, and present at investigator meetings.

Draft site agreements and budgets.

Coordinate and participate in protocol concept, protocol synopsis, template ICF, and final protocol development.

Determine patient recruitment strategies and operational feasibility and implementation of clinical trial objectives.

Plan and manage study timelines.

Develop and review outsourcing specifications for RFPs, vendor, and resource management.

Author and refine study monitoring plan.

Able to train and provide oversight to a team of CRAs (trip report review, TCR review, co-monitoring, mentoring, etc).

Coordinate ongoing study team review of data.

Must be able to manage and communication the operational plan for a given project including timelines, key deliverables, internal and external resources/costs and key data issues.

The ideal candidate has to demonstrate strong interpersonal skills, communication skills, writing, project planning, leadership, negotiation and presentation skills, as well as an ability to contribute creative, practical solutions to problems.

Conduct on-site monitoring and site management responsibilities for assigned sites.

Qualifications:

Basic qualifications:

BS/RN/RPh degree with 5+ years of clinical operations experience or MS degree with 3+ years of clinical operations experience including 1+ year of independent site monitoring/management experience.

Preferred qualifications:

Strong site management, site monitoring and clinical operations experience.

Thorough understanding of FDA, ICH, and GCP guidelines as well as a strong understanding of cross-functional clinical processes including data management, biostatistics, and medical writing.

Strong leadership, planning and project management skills.

Good interpersonal and negotiations skills.

Strong verbal and written communications and presentation skills.

Strong problem solving skills with the ability to contribute creative, practical solutions to problems.

Prior CRA oversight responsibility.

Ability and willingness to travel up to 35% of the time (international and domestic).

Willingness to work in different therapeutic areas.


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