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Manager, IRT – Clinical Data Operations & Compliance

78% Flex
EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE
Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 
United States

Agios Pharmaceuticals logo
Agios Pharmaceuticals Pharmaceuticals SME https://www.agios.com/
201 - 500 Employees
See more Agios Pharmaceuticals offers

Job description

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Your missions

Manager, IRT – Clinical Data Operations & ComplianceWho 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 genetically defined 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. The impact you will make:Agios Pharmaceuticals is searching for a dynamic Manager, IRT to join our growing Clinical Systems and Data Solutions team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Manager, IRT will assist and/or function as the business system owner for outsourced IRT services at Agios. In partnership with key stakeholders and vendors, you will drive all IRT implementations and system changes in accordance with our IRT standards, protocols, and SOPs. Study teams will be highly dependent on your knowledge and expertise in a fast-paced, dynamic environment. What you will do:** - Oversee IRT development activities between the Vendor and the Agios stakeholders. - Work with clinical trial project teams and management to adhere to our IRT Standards and project timelines. - Perform UAT script writing and driving UAT completion with Agios stakeholders. - Act as the subject matter expert during all phases of an IRT build or change control. - Support data integrations from / to IRT systems and manage data transfers with vendor and Agios stakeholders. - Assist with or drive vendor oversight and governance. - Act as the subject matter expert for triage of study-specific issues, without heavy reliance on the IRT vendor. - Identify process or knowledge gaps and be able to address them through process modifications or through training.

What you bring: - Bachelor’s degree and 5+ years relevant work experience with a focus on IRT development and/or IRT vendor oversight. - An ideal candidate will have a mix of technical project management or business analyst experience as an IRT vendor, as well as some vendor oversight experience from the Sponsor side. - Strong project management skills, and ability to effectively lead complex IRT design discussions and collaborate with various business functions. - High attention to detail including proven ability to manage multiple, competing priorities - Demonstrated ability to influence change - Excellent written and oral communication skills - Flexibility and cross functional collaboration

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. - 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.

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Soft Skills

  • Interpersonal Skills
  • Team Collaboration

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