Sarepta Therapeutics
Senior Director, External Data Management
Sarepta Therapeutics, Cambridge, Massachusetts, us, 02140
Why Sarepta? Why Now?The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta OffersAt Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website:
https://www.sarepta.com/join-us
The Importance of the RoleThis individual is a seasoned clinical data management leader and reports to the Head of Clinical Data Management. This role is accountable to oversee and lead all activities associated with the collection, transfer, and quality of clinical trial data collected from external sources (i.e., central labs, specialty data providers, eCOA, IRT, etc.) across the clinical data management function. This individual provides expertise in clinical data management and leads across the Data Management function to effectively support all clinical trials across all Sarepta’s clinical development programs.
The Opportunity to Make a Difference
Accountable for all Data Management timelines and quality of external data deliverables in collaboration with other functions
Develop and manage the standards, data transfer specifications, and data flow for collection and ongoing review of external clinical trial data
Develop strategies and transition plans to implement more process automation and real-time data flow from external vendor partners
Collaborate closely with IT colleagues on the development, implementation, and management of an integrated clinical trial data repository for the data management team
Ensure that a well-functioning governance structure is in place and followed for CRO and all external vendor partners. Measures vendor success through mutually agreed key performance indicators (KPIs) and service level agreements (SLAs)
Provide technical and process leadership for external data to cross-functional teams
Forecast and manage Data Management resources and budget to meet current and future business needs
Select and manage external data vendors to meet regulatory requirements, quality standards, timelines and budget constraints
Oversee directly or through team members ongoing external data updates, data reconciliations between EDC and external sources, and ongoing data cleaning to enable high-quality data snapshots and soft locks to support various trial and/or program activities
Oversee directly or through team members database lock activities to ensure high quality data with proper documentation and inspection readiness
Collaborate with Clinical Operations Excellence team members in leading, developing, and implementing cross-functional platform solutions to support all aspects of data collection and reporting
Ensure close collaboration of Data Management with other functions in various activities to achieve program and trial level goals
Devise or oversee development of external data vendor KPIs and metrics to inform cross-functional teams and support vendor oversight
Responsible for coaching, mentoring, and performance management of direct reports
More about You
Bachelor's degree or higher, preferably in a data science or health related discipline
10+ years of clinical data management experience in pharma/biotech industry
Previous experience and leadership in managing external data providers for Data Management (i.e., central labs, specialty vendors, eCOA, IRT, etc.)
Strong expertise in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industry
Strong technical skills in database design, data transfer requirements, and data flow
Previous experiences in leading machine learning, AI, and robotic process automation (RPA) projects in clinical development is preferred
A strong cross-functional leader who understands and can speak to the needs of organizational stakeholders
Experience in managing an outsourced data management model
Familiarity with GCP, ICH, and FDA and other health authority regulatory requirements as applicable for clinical data management
Familiarity with CDISC model and associated CDASH and SDTM standards
Experience in leading Data Management for a BLA or NDA
Excellent written and oral communication skills
Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
7 years of experience in leading/managing a Data Management team, including hiring, managing, mentoring and/or developing direct reports
#LI-REMOTE
#LI-TD1
What Now?We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $216,000 - $270,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
#J-18808-Ljbffr
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta OffersAt Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website:
https://www.sarepta.com/join-us
The Importance of the RoleThis individual is a seasoned clinical data management leader and reports to the Head of Clinical Data Management. This role is accountable to oversee and lead all activities associated with the collection, transfer, and quality of clinical trial data collected from external sources (i.e., central labs, specialty data providers, eCOA, IRT, etc.) across the clinical data management function. This individual provides expertise in clinical data management and leads across the Data Management function to effectively support all clinical trials across all Sarepta’s clinical development programs.
The Opportunity to Make a Difference
Accountable for all Data Management timelines and quality of external data deliverables in collaboration with other functions
Develop and manage the standards, data transfer specifications, and data flow for collection and ongoing review of external clinical trial data
Develop strategies and transition plans to implement more process automation and real-time data flow from external vendor partners
Collaborate closely with IT colleagues on the development, implementation, and management of an integrated clinical trial data repository for the data management team
Ensure that a well-functioning governance structure is in place and followed for CRO and all external vendor partners. Measures vendor success through mutually agreed key performance indicators (KPIs) and service level agreements (SLAs)
Provide technical and process leadership for external data to cross-functional teams
Forecast and manage Data Management resources and budget to meet current and future business needs
Select and manage external data vendors to meet regulatory requirements, quality standards, timelines and budget constraints
Oversee directly or through team members ongoing external data updates, data reconciliations between EDC and external sources, and ongoing data cleaning to enable high-quality data snapshots and soft locks to support various trial and/or program activities
Oversee directly or through team members database lock activities to ensure high quality data with proper documentation and inspection readiness
Collaborate with Clinical Operations Excellence team members in leading, developing, and implementing cross-functional platform solutions to support all aspects of data collection and reporting
Ensure close collaboration of Data Management with other functions in various activities to achieve program and trial level goals
Devise or oversee development of external data vendor KPIs and metrics to inform cross-functional teams and support vendor oversight
Responsible for coaching, mentoring, and performance management of direct reports
More about You
Bachelor's degree or higher, preferably in a data science or health related discipline
10+ years of clinical data management experience in pharma/biotech industry
Previous experience and leadership in managing external data providers for Data Management (i.e., central labs, specialty vendors, eCOA, IRT, etc.)
Strong expertise in clinical data management for Phases I-IV clinical trials and complex study designs in pharma/biotech industry
Strong technical skills in database design, data transfer requirements, and data flow
Previous experiences in leading machine learning, AI, and robotic process automation (RPA) projects in clinical development is preferred
A strong cross-functional leader who understands and can speak to the needs of organizational stakeholders
Experience in managing an outsourced data management model
Familiarity with GCP, ICH, and FDA and other health authority regulatory requirements as applicable for clinical data management
Familiarity with CDISC model and associated CDASH and SDTM standards
Experience in leading Data Management for a BLA or NDA
Excellent written and oral communication skills
Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
7 years of experience in leading/managing a Data Management team, including hiring, managing, mentoring and/or developing direct reports
#LI-REMOTE
#LI-TD1
What Now?We’re always looking for solution-oriented, critical thinkers. So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $216,000 - $270,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package. Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
#J-18808-Ljbffr