Senior Manager, Clinical Data Management

Kinsley Power Systems; Cambridge (MA); Hybrid; USD 127,000 - 191,000; Full time

Job summary

An established industry player is seeking a Senior Manager in Clinical Data Management to lead data management activities and ensure compliance with FDA standards. This role offers the flexibility of remote or hybrid work arrangements, allowing you to thrive in an environment that values your contributions. You will oversee critical data management processes, collaborate with cross-functional teams, and drive initiatives that enhance data quality and safety. Join a forward-thinking company committed to making a difference in patients' lives while enjoying a competitive compensation package and a culture that prioritizes professional growth and inclusivity.

Benefits

Premium benefits package

Flexible work arrangements

Competitive performance-based compensation

Commitment to diversity

Psychological safety initiatives

Qualifications

• 5+ years of experience as a Clinical Data Manager or related.
• Experience with FDA quality database submissions and data safety.

Responsibilities

• Oversee data management activities performed by CROs.
• Develop and implement departmental initiatives and timelines.

Skills

Clinical Data Management

FDA Requirements

User Acceptance Testing (UAT)

Data Validation

Project Management

Education

Master’s degree in Chemistry

Master’s degree in Data Science

Job description

Senior Manager, Clinical Data Management

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

What you will do:

The Senior Manager, Clinical Data Management will oversee all data management activities performed by CROs including generation and review of metric status and patient tracking reports. Ensure major DM deliverables and milestones are met. Assist in the review of vendor proposals, budgets, scopes of work. Review and manage key documents such as data management plans, guidelines for Case Report Form (CRF) completion, data review, SAE reconciliation, vendor oversight, TMF plans, and data audits. Develop and oversee CRO generation of data edit check specifications (DVS). Participate in user acceptance testing (UAT) of clinical databases. Spearhead internal study team in data review. Perform data review for quality issues and general data trends. Define and oversee data transfer specifications for external data sources. Produce in-process data reports and data visualizations to facilitate decision making on clinical trials. Liaison with cross-functional team members and external vendors to ensure completion of all timelines and study-related tasks. Develop and implement departmental initiatives. Telecommuting available anywhere in the United States.

What you bring:

Requires a Master’s degree in Chemistry, Data Science, or a related field plus five (5) years of experience as a Clinical Data Manager, Clinical Data Specialist, or related. Must possess five (5) years of experience with each of the following: (a) leading and managing projects and ensuring FDA requirements for quality database submissions; (b) protocol review, CRF development, database set up, data validation, and Serious Adverse Events (SAE) reconciliation; (c) User Acceptance Testing (UAT); (d) Query generation and resolution; (e) Clinical regulations (i.e. ICH, GCP, and Good Clinical DM Practice); (f) ensuring data safety of clinical data and local lab data reconciliation. Telecommuting available anywhere in the United States.

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
  • The current base salary range for this position is expected to be between $127,219 and $190,828 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.

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