Senior Clinical Data Manager

Employer
PellePharm
Location
San Francisco, CA
Salary
Competitive market compensation + benefits
Posted
Jun 24, 2019
Required Education
Bachelors Degree
Position Type
Full time

Company

PellePharm, Inc. is a privately held biopharmaceutical company based in the San Francisco Bay Area. Founded by world leaders in hedgehog signaling, PellePharm is committed to targeting rare genetic dermatological conditions, including Gorlin Syndrome and Basal Cell Carcinomas (BCCs), at the source. PellePharm is committed to improving the quality of life for those suffering from Gorlin Syndrome and BCCs by providing an easy-to-use topical gel that eliminates the need for regular, painful surgeries. The U.S. Food and Drug Administration awarded a Breakthrough Therapy Designation and Orphan Drug Designation to Patidegib after presenting positive Phase II data evaluating the safety and efficacy of the therapy in patients with Gorlin Syndrome. PellePharm is aiming to initiate the Phase III trials of the topical hedgehog inhibitor in 2019. PellePharm recently announced a partnership with Leo Pharma, a Dutch pharmaceutical company, which enables the company to execute the Phase III studies and marks Leo Pharma’s entrance in rare skin disease.

Role

The Senior Clinical Data Manager is responsible for overseeing Data Management operational activities through all study phases. This includes supporting the design, development, validation, implementation, maintenance, and close-out of clinical study databases for all clinical studies. The Senior Clinical Data Manager will ensure a high level of quality for deliverables from Data Management vendors.

Responsibilities:

The Senior Clinical Data Manager is responsible for the following activities:

  • Oversee Data Management CRO, vendors and sites to ensure that data management activities are performed consistently, and deliverables are of high-quality
  • Participate in vendor selection and contract negotiation process, including RFPs and bid defense meetings, as applicable. Evaluate and define review tools and reports necessary for successful data review
  • Represent Data Management in study team meetings and facilitates cross-functional activities (e.g., clinical data listing reviews, database lock activities, etc.)
  • Oversee management of the clinical database and central lab database
  • Manage Patient Reported Outcome database
  • Coordinate and/or provides training on data management systems, reporting tools, etc.
  • Author, review and/or approve various Data Management study related documents and plans (e.g., Data Management Plans, eCRF Specifications, Edit Check Specifications, eCRF Completion Guidelines, Data Transfer Plans, etc.) and ensure documents are maintained throughout the duration of the study
  • Develop Data Management SOPs
  • Oversee data cleaning and database closure
  • Coordinate migration of legacy clinical data
  • Oversee data submission for NDA
  • Program/update reports in JReview

Must Have Qualifications:

  • Minimum of 10 years of Data Management experience in the pharmaceutical and/or biotech space
  • Bachelor’s degree or equivalent
  • Working knowledge of GCP ICH and GCDMP guidelines and the clinical development process
  • Experience as a Data Management Lead in all phases of clinical trials (start-up, maintenance, and close-out)
  • Ability to program JReview reports
  • Experience with and working knowledge of Medidata Rave
  • Experience of selecting and managing vendors
  • Previous experience with database design
  • Previous experience with User Acceptance Testing
  • Proven ability to author validations, CRF completion guidelines
  • Previous experience over overseeing query management, raising manual queries
  • Previous experience with database closure
  • Previous experience of participation in NDA submission
  • Previous experience of creation/maintenance of DM SOPs
  • Proficient with Microsoft Suite
  • Experience with Captivate is a plus
  • Strong interpersonal, communication (written and verbal), and organizational skills
  • Demonstrated ability to work independently, as well as part of a multi-functional study team
  • Ability to multi-task, prioritize and solve problems

Personal Characteristics:

  • Integrity
  • Highly organized
  • Excellent collaborative skills
  • Self – starter, able to work independently
  • Strong problem solving and organizational skills
  • Leads by example
  • Can do attitude

Compensation

Other than working with a great team of smart, passionate and energetic people, PellePharm also offers a competitive salary and benefits package that includes 100% coverage of health care premiums, life insurance, 401k, and perks. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career.

Pellepharm is an equal opportunity employer and values diversity.  All employment is decided on the basis of qualifications, merit and business need.