Head, Clinical Data Management

Location
Emeryville, CA, United States
Posted
Jan 04, 2019
Ref
oNG68fwr
Discipline
Clinical, Clinical Data
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
COMPANY DESCRIPTION

Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 3,500 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA, contributes important ophthalmic research and development efforts worldwide and is home to our regional business teams. This office currently employs about 140 people.

With the passionate support of our Japanese parent company and its 125-year heritage, Santen is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.

We are driven by and committed to our mission: Delivering Vision, Every Day. Additionally, our Corporate Strategy Policy for FY18-FY20 has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.

We are in search of top talent to help us meet our aggressive and important goals.

PRIMARY PURPOSE OF POSITION

The position of Head, Clinical Data Management (CDM) should be a strong and capable leader for Clinical Data Management and a master of the industry data standards as well as standards for government regulatory agencies. He or she will manage and mentor the CDM staff in the US and Japan, and lead the effort to develop and maintain all standard operating procedures and work instruction guidelines related to CDM activities. As the Head of CDM, he or she leads business activities of the CDM group within Data Science; oversees the day to day CDM support of Santen's clinical studies, including EDC build, UAT, data cleaning, data reconciliations, query generation and resolutions, database snapshots, and database locks. This position reports to Head of Data Science, and closely works with the leadership of Biostatistics, Statistical Programming, Clinical Operations, Pharmacovigilance and other functional areas, to ensure the best CDM support. This position is essential for successful Santen Data Science support for these organizations.

JOB DESCRIPTION

We are looking for an individual with extensive experience in Clinical Data Management who has successfully managed a group of data managers. This person must have previous experience leading a CDM organization that provided high quality data to support regulatory approval of medications in North America, Europe or Asia.

MAJOR DUTIES OF POSITION:
  • Recruit and manage CDM staff and consultants
  • Oversee the preparation and maintenance of all CDM related SOPs and work instructions
  • Lead the efforts for creating and maintaining standardized eCRFs
  • Set-up and maintain standardized processes for EDC Build, Edit Check Specifications, UAT, and EDC Validation
  • Establish the CDM group's MBOs, aligning with corporate goals, and work with the Head of Data Science to develop and monitor the department strategic direction and its alignment with company strategies
  • Participate in new drug development programs as a Subject Matter Expert (SME) in CDM
  • Participate in project teams as Santen's CDM Head
  • Guide data managers in their work with CRAs, Clinical Study Managers, Pahrmacovigilance staff, Clinical Scientists, study biostatisticians and statistical programmers to provide clinical database management for all Santen clinical studies and to ensure the quality of clinical data for every Santen clinical study
  • Review all study related documents and forms as necessary
  • Create effective CDM outsourcing models in the US and Japan, and execute the models to meet Santen's business needs
  • Prepare budgets for CDM related budget items and forecasts
  • Keep abreast of literature/advancements in data collection and repository systems as well as data structures in own and related fields of drug development programs
  • Foster open communications among cross-functional groups within the Data Science department as well as outside of the department to establish seamless and transparent workflows
  • Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines
  • Develop staff by assessing, coaching, providing appropriate training, setting goals, and recognizing those who make significant contributions to business objectives
  • Develop and maintain a standard documentation process for CDM activities

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Minimum of 15 years of CDM experience in the pharmaceutical industry, with ophthalmic pharmaceutical experience preferred
  • BS degree or higher and more than 8 years of managerial experience
  • Full knowledge of regulatory requirements for clinical trial data
  • In-depth knowledge of regulatory regulations and ICH guidelines in drug development and approval with good experience in multiple FDA and EMA filings
  • Solid understanding of data management collection tools, experience with Medidata RAVE is preferred
  • Excellent written and verbal communication skills and collaborative working style
  • Experience working in an international work environment is preferred
  • Good organizational and problem-solving skills, as well as the ability to evaluate resource needs
  • Experience reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans
  • Solid knowledge of Clinical Data Management procedures with good ability to develop and implement a high quality data system and associated procedures, and perform systematic data quality control management.
  • Ability to lead standardization processes in Data Science areas
  • Ability to build a rapport and trust with others through leadership and dependability
  • Ability to document deliverables following procedures with the utmost rigor and attention to detail
  • Must be able to travel internationally, as needed
  • Experience managing direct reports in a different country and time zone is preferred

For more information about our company and the work experience, please visit www.santenusa.com