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Spotlight Preferred Member Company
Morphic Therapeutic
Waltham, Massachusetts, United States (hybrid)
4 days ago

Description

About Morphic Therapeutic

Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, integrity, and beauty.  

Job Description: 

The Senior Manager/ Associate Director of Clinical Data Management will be responsible for supporting data management activities across all study phases for Morphic Therapeutic clinical trials. The successful candidate will oversee and help to develop accurate clinical data capture tools and processes for our studies that ensure accurate, consistent, high quality, and complete study data acquisition to support planned analysis. The 

individual must have a good understanding of and substantial experience with clinical trial guidelines and 

procedures such as ICH-GCP, 21 CFR part 11 and CDISC. The position will be responsible for preserving data 

integrity and adhering to timelines for regulatory submissions and publications. The Senior Manager/ Associate Director of Clinical Data Management will report to the Director of Data Management and will work closely with all other functional groups that comprise the Clinical Study Team. 

Essential Job Functions: 

Responsibilities 

 Serve as DM project manager/lead managing assigned study project timelines ensuring overall

deliverables/timelines and vendor responsibilities are met.

• Provide oversight of Contract Research Organizations (CROs), specialty vendors, and consultants that are involved with the clinical data management.

• Define, measure, and monitor vendor performance metrics to ensure quality of data management

deliverables.

• Represent Data Management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Morphic, for all data related deliverables.

• Collaborate with cross-functional teams to understand team objectives, define requirements, and

translate into actionable plans.

• Identify and leverage available technologies to assist in coordination, planning, and completing Morphic objectives.

• Participate in the development, implementation and maintenance of global data standards and working procedures.

• Reviews study protocols, Statistical Analysis Plans, and other clinical trial documents, providing Data

Management input.

• Perform data reviews for quality issues, identify general data trends and facilitate data review meetings with relevant cross-functional team members.

• Facilitate Morphic UAT for database builds and or migrations to manage any impacts from mid-study

updates to the EDC database and other data collection systems.

• Participate in review of budgets/invoices relating to Data Management activities

• Develop and maintain strong, collaborative relationships with other cross-functional groups, as well as vendor partners.

Qualifications:

Requirements

 Bachelor's degree or equivalent

• S+ years of direct experience in clinical data management within the biotech or pharmaceutical industry

• Exceptional knowledge and experience in clinical data management processes.

• Proficient in multiple EDC platforms, with strong understanding of database design and database

concepts and related processes (database builds, updates, locks, etc.).

• Expert knowledge of CDSIC Standards (CDASH/SDTM}

• Direct experience with data visualization tools (e.g., TIBCO Spotfire, elluminate, Power Bl, Tableau, SAS JMP etc.) and managing non-EDC data sourced from laboratories, eCOA, IRT, etc.

• Experience developing and managing vendor relationships.

• Prior experiences with inspection readiness and regulatory submissions.

• Working knowledge of SAS and SQL.

• Experience with budget planning.

• Self-starter and must function well under minimal supervision.

• Comfortable in a fast-paced small company environment, able to manage multiple projects simultaneously and handle changing priorities. 

 Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives.  In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.    



Job Information

  • Job ID: 67968840
  • Workplace Type: Hybrid
  • Location:
    Waltham, Massachusetts, United States
  • Company Name For Job: Morphic Therapeutic
  • Position Title: Senior Manager/ Associate Director, Clinical Data Management
  • Job Function: Data Management
  • Job Type: Full-Time
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 5-7 Years

Morphic Therapeutic is leading the development of a new generation of oral integrin drugs. Drawing on discoveries made in the lab of Scientific Founder Tim Springer, Morphic is advancing preclinical programs in autoimmunity, fibrosis, vascular disorders and immuno-oncology. Morphic was created in 2015 with support from Timothy Springer, PhD, Polaris Partners, Schrödinger Inc., and ShangPharma. New investors SROne, Pfizer Ventures, Omega Funds and AbbVie joined for the Series A round in June 2016. In September 2018, ...

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