|Title:||Senior Director, Data Management & Programming|
Venatorx Pharmaceuticals, Inc., a private, clinical-stage pharmaceutical company located in Malvern, PA, has an opening for a Senior Director, Data Management & Programming within our Development team. We are looking for passionate, motivated, and intellectually curious professionals to join us at this very exciting time of growth as we continue in our pursuit to discover and develop new medicines to treat drug-resistance infections. In August 2019, we initiated enrollment in Phase 3 trial of cefepime/VNRX-5133 in patients with complicated urinary tract infections (cUTIs) and expect top-line results by end of 2020. VNRX-5133 is an injectable beta-lactamase inhibitor (BLI) that features selective and potent in vitro activity against both serine- and metallo-beta-lactamases (MBLs).
The Senior Director, Data Management & Programming is responsible for providing oversight for development of Electronic Data Collection systems (EDC) for use with clinical trials, oversight of data management activities and vendors, assist with the development and implementation of global clinical and safety database repositories, and programming support for the summarization and analyses of clinical trial data as well as creation of data submission documents for all regulatory submissions.
- Directs the overall data management supporting assigned projects/programs for research studies (Phase I – Phase IV) and publications within the scope of project timelines.
- Directs the overall SAS programming process supporting projects/programs for research studies (Phase I – Phase IV) and publications within the scope of project timelines.
- Directs the creation/standardization of case report forms for all clinical trials (Phase I – Phase III).
- Directs the creation of and acceptance of EDC systems created by outside vendors for collection of clinical data (Phase I – Phase IV).
- Works closely with clinical project team in developing and/or defining data structure, ongoing data quality standards and clinical data acceptance rules for assigned clinical studies.
- Initiates, manages and coordinates the activities of outside vendors for data management and/or programming.
- Works with consultant statisticians and/or vendors that provide statistical input for clinical studies and publications to align data management and statistical requirements.
- Partners with internal team(s) to plan and implement Venatorx’s clinical programming and data management environment including the SAS software validation and maintenance, standard programming tools (macros/template programs/etc.) and standard programming processes.
- Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
- Assists in the development and implementation of internal database standards (including EDC and CDISC input as well), external data transfer and acceptance specifications, and documentation processes for clinical data.
- Develop and update SOP's associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.
- Compiles all clinical data in appropriate submission format for regulatory submissions in all geographies.
- Ensure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines.
Successful candidates will be able to demonstrate:
- BA/BS, preferably in the scientific/healthcare field.
- Minimum 10 years of Data Management in the pharmaceutical/clinical research industry with 3-5 years’ experience in a managerial role (projects/personnel).
- Knowledge and understanding of the principles, concepts, methods and standards of Clinical Data Management (CDM).
- Ability to direct and manage the activities of outside Data Management vendors.
- Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.
- Excellent time management, ability to coordinate workload and meet established deadlines.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Ability to review data transferred electronically, identify issues that may exist, and anticipate future needs/risks and plan accordingly.
- Skills in the use of SAS programming, database management, word processing, spreadsheet and presentation software.
- Knowledge of current and emerging trends in data management of clinical trials data.
- Attention to detail and the ability to work individually, within a cross-functional team, as well as with external partners and vendors.
- CRF design/Database design/CRF Completion/Data review skills
- Possess strong written and verbal communication skills