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Associate Director, Clinical Data Management

Boston, MA 02108

Posted: 01/10/2024 Category: Pharmaceutical Job Number: 330669-0_1-1 Salary: $175,000 - $185,000

Job Description

Smith Hanley Associates
Associate Director, Clinical Data Management
Remote/Full Time

Our client is seeking a seasoned professional to lead the Data Management function and support their mission to bring novel medicines to patients with unmet medical needs. As the Data Management Lead, you will manage direct reports, assist with company strategy, and collaborate with stakeholders to uphold the quality and integrity of clinical trial data, while identifying and minimizing potential risks to studies/projects.

Responsibilities:
In this pivotal role, you will play a crucial part in planning and executing data management activities within one or more clinical studies or projects. Key responsibilities include:

Leading data management activities for clinical studies and managing a small team.
Aligning team objectives with company strategy and contributing to strategic planning.
Selecting and managing appropriate data capture systems, such as Electronic Data Capture (EDC) or electronic Clinical Outcome Assessment (eCOA).
Conducting in-house reviews of clinical trial data, participating in quality control activities, and managing study documents.
Overseeing financial aspects, including participating in the selection of CROs/contractors and ensuring adherence to timelines and processes.Participating in the review and update of data management processes and providing input to various study documents.
Evaluating new data collection systems for suitability and adherence to regulatory requirements.

Qualifications:
Bachelor's/Master's degree in a scientific discipline.
10+ years of clinical data management experience. Experience leading studies required.
Previous experience managing direct reports required.
Demonstrable experience in implementing new data management processes and systems.
Knowledge and experience in clinical development strategic planning and the design of clinical studies.
Familiarity with GCP guidelines, global regulatory requirements, and FDA regulations.
Strong analytical and problem-solving skills, with the ability to oversee and manage CROs' data management activities.
Some travel to the East Coast required.

If you are a strategic thinker with strong leadership skills and a passion for advancing clinical data management in the pharmaceutical industry, we invite you to apply.

Meet Your Recruiter

Nihar Parikh
Executive Recruiter

Nihar specializes in the clinical domain and works across biostatistics, clinical trials/research, data management, health economics/RWE, medical affairs, statistical programming, and other R&D areas within pharma and biotech. He has more than ten years of recruiting experience and attributes his success to the ability to build good relationships, listen attentively, be proactive, continuously self-improve, and show empathy. Nihar plans to carry Smith Hanley’s stellar reputation in the pharma business for many years to come. Outside of work, Nihar likes to spend his time following Chicago sports, travel, podcasts, yoga, golf, and investing. 

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About Boston, MA

Ready to take your career to new heights? Explore our job opportunities in the vibrant Boston, Massachusetts area! Known for its rich history, world-class universities, and thriving tech and healthcare sectors, Boston offers a unique blend of opportunity and charm. Imagine working near iconic landmarks like the Freedom Trail, indulging in delicious clam chowder, catching a show at the Boston Opera House, or cheering on the beloved Red Sox at Fenway Park. With renowned art galleries, theaters, and the stunning Boston Common right at your doorstep, there’s no shortage of ways to enjoy work-life balance in this dynamic city. Discover your next career move in Boston today!

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