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Clinical Data Manager

Waltham, MA Clinical Development & Operations - Clinical Development Full Time
Company Summary:
Deciphera Pharmaceuticals is a pre-commercial stage biopharmaceutical company focused on improving the lives of cancer patients by addressing key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off” or inactivated conformation. These investigational therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their responses to treatment. 

We offer an outstanding culture and opportunity for personal and professional growth based on these key principles:
·       providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
·       a diverse and multi-disciplinary workforce
·       dedicated and talented people who are passionate about achieving excellence in all they do
·       a work environment that allows you to balance your priorities
·       above all else, a commitment to the patients we serve

We are seeking a Clinical Data Manager who can contribute to data management activities in support of Deciphera studies across all stages of clinical drug development. This position will report to the Associate Director of Data Management and will be located in the Waltham, MA office.
 
The Clinical Data Manager is responsible for the performance of data management tasks from study start-up, inclusive of database design, through database lock for assigned projects within electronic data capture (EDC) systems. S/he is responsible for assisting with the creation of CRFs, actively involved in User Acceptance Testing (UAT), data cleaning, query generation and management, and assisting in the review of relevant data management documents. The Clinical Data Manager is responsible for overall data quality and documentation.
Key Responsibilities
  • Assist in all the study specific CDM tasks
  • Forecast timelines and resources required to complete study-specific tasks on time and with high quality
  • Leads execution of CDM tasks according to the agreed upon timelines, mitigating risks as appropriate
  • Plans and facilitates internal and external study meetings
  • Assists in developing Data Management Plans and other CDM documents in collaboration with other functions
  • Collaborates with vendors and cross-functional teams to develop Data Transfer Specifications
  • Reviews operational clinical study documentation including project timelines, meeting minutes, memos and study notes to file
  • Ensures that delegated and outsourced tasks are performed according to quality standards
  • May be required to review clinical protocols and provides input
  • Participate in eCRF design and Data Validation specifications
  • Ensures that study documentation is filed according to SOPs and Work Instructions; leads QC of study files for completeness and accuracy
  • Facilitates cross-functional data review for assigned studies
  • Generates and analyzes study metrics and informs cross-functional study teams
  • Assists in the development of eCRF Completion Guidelines
  • Participates in User Acceptance Testing for clinical study databases
  • Leads data review for accuracy, completeness, and consistency and performs QC of queries as appropriate
  • Oversees e-Data reconciliation process
  • Adheres to study timelines and quality standards
  • Manages time effectively; able to prioritize tasks and forecast task completion durations
  • Required Qualifications
  • Bachelor’s degree in a related field & 2 years of experience in clinical data management required OR Master’s degree & 1 years of experience in clinical data management.
  • 1 year of experience in leading small project teams preferred.
  • Working knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
  • Skilled in use of computer technology, including clinical trial databases and applications (e.g., IBM Clinical Development, Medidata Rave EDC) and ability to learn new applications.
  • Excellent interpersonal, communication, and organizational skills with the ability to work both independently and in a team environment.