Manager/Sr. Manager, Clinical Data Management

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 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 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 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 Manager/Sr. Manager, Data Management will be responsible for supporting data management activities across all study phases for Morphic Therapeutic clinical trials. The successful candidate will oversee outsourced studies to ensure the acquisition of

accurate, consistent, high quality, and complete study data 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 Lead Data Manager will report to the Senior Director of Data Management and will work closely with all other functional groups that comprise the Clinical Study Team.

Essential Job Functions:

• 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 clinical data management.

• 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.

• Reviews study protocols, 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.

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

• Develop technical specifications for data management programming and communicate needs to information technology partners.

• Analyze clinical data using appropriate statistical tools.

• Performs data review in support of data cleaning, including review of data listings, exception reports and patient profiles.

• Perform ongoing review of study documentation in the trial master file (TMF) to always ensure audit readiness.

Qualifications:

Required

• Bachelor's degree or equivalent

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

• In-depth 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.).

• Working knowledge of CDSIC Standards (CDASH/SDTM

• Knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects.

• Knowledge of GCPs and regulatory agency guidelines.

• Familiarity with medical terminology.

• Great verbal and written communication skills.

• 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.

Desired

• Experience with data visualization tools (e.g., TIBCO Spotfire, elluminate, Power Bl, Tableau, SAS JMP etc.)

Cultural Fit:

Our culture is collaborative, one where people enjoy coming to work. We are a small, entrepreneurial company where everyone pitches in and works together to do whatever it takes to get things done. Our team is passionate, enthusiastic, and committed.

We have a fast-paced, high accountability environment. We have a flat organization, and our leaders lead through influence and interpersonal skills, not command and control. Everyone on the team, including our CEO, is an individual contributor.

We seek an individual for this position who shares our values and our enthusiasm about bringing new medicines to the patients and families that need them. We seek someone who will enjoy working in a small company environment and be motivated by the

opportunity to directly influence and help shape the future direction and culture of our company.

 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.