Senior Clinical Project Manager at Advanced Group in Cambridge, Massachusetts

Job Description:

OVERVIEW

We are currently searching for a skilled professional to join a well-known client's team as a Senior Clinical Project Manager in Cambridge, Massachusetts. The Senior Clinical Project Manager role will plan, implement, execute, and manage one or more clinical research studies. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.


RESPONSIBILITIES

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  Lead global clinical trial(s), may be responsible for multiple trials simultaneously


• Author, review, and contribute to clinical study documents


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  Deliver the clinical study in accordance with the clinical development plan/strategy and timeline


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  Evaluate and approve study-related plans generated by Clinical CROs and vendors


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  Serve as the subject matter expert for the study during regulatory inspections


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  Execute the clinical study in accordance with applicable regulations and guidelines


• Anticipate potential study issues and prepare contingency plans


• Address site, CRO, and vendor-related issues


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  Escalate and communicate any study-related issues


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  Monitor, train, and manage CRO/other clinical vendor activities


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  Produce regular/ad hoc reports and presentations


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  Review budgets and contracts with CROs, vendors, and investigative sites


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  Request and evaluate proposals/change orders from CROs and vendors


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  Guide team through vendor-selection process and provide input into contracts, change orders, and/or work orders


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  Maintain knowledge of therapeutic area, current medical practice, and regulations to ensure best practice across all activities


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  Support department initiatives and process improvements


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  Oversee and/or mentor other Clinical Operations staff


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  Attend relevant symposia, conferences, and scientific meetings


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  Create, develop, and provide training support to meet training needs across Clinical Operations

EXPERIENCE

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  Minimum of 8 years of clinically-related experience with a pharmaceutical company, CRO, or similar organization required


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  Strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines


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  Ability to articulate complex ideas in understandable business terms to all levels of leadership and project teams required


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  Strong knowledge of applicable computer and project management software packages


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  Knowledge of financial budgeting and forecasting or reporting preferred


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  Excellent written and oral communication skills


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  Detailed knowledge of current global regulatory requirements/guidelines governing clinical research and GCP


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  Retina and/or rare disease experience desired


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  Travel required - up to 20% domestic and/or international

EDUCATION

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  Minimum of Bachelor's Degree or nursing qualification required, scientific/health care field preferred

To be a best-fit your strengths must include:

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  Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.


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  Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.


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  Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.


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  Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.


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  Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.


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  Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.


Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.


It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.


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