Senior Clinical Data Manager
The Sr. Clinical Data Manager (CDM) leads and monitors the collection, processing, data entry and quality control of study data. She/He is responsible for effectively managing timelines, quality and delivery of data for assigned projects that are in support of clinical trials research. She/He develops and maintains successful working relationships with their team to ensure and maintain data integrity and quality.
Applying GCP and GCDMP principles, the Sr. CDM manages the protocol/study specific tasks including coordinating clinical and laboratory database deliverables, working with collaborators on data content requirements, leading data quality and closeout activities throughout the data management lifecycle.
The position of Sr. CDM is also expected to manage basic science questions/queries, clinical development tasks associated to the management of trial data, and internal Omeros projects. The Sr. CDM adheres to Omeros Standard Operating Procedures (SOPs), Work Practices, applicable clinical trial regulations, and study confidentiality requirements and functions with limited supervision in operational and technical matters within defined procedures and practices.
Good things are happening at Omeros!
Come join our Omeros Clinical Team!
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros’ proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
- Manage study/project implementation including but not limited to leading Omeros team members through CRF, lab, and other data collection processes, reporting and analysis requirements, study/project documentation and training
- Effectively manage assigned protocol/study, establish timelines and milestones in conjunction with department management, and monitor and communicate ongoing status and progress
- Ensure rapid resolution of issues/conflicts using appropriate internal and/or external resources. Track and manage the escalation of issues to ensure appropriate resolution in a timely manner
- Participate in development of a protocol/study from draft status to optimize the collection of accurate and high-quality data
- Work with project sponsors, stakeholders and corss-functional team members to define project requirements, scope, risks, organization and approach
- Act as subject matter expert for data management issues between study team staff and external domestic and international research sites for assigned studies
- Lead the development of Case Report Forms (CRFs) for assigned studies
- Be accountable for the design of the protocol/study specific database for assigned studiesa
- Be accountable for the maintenance of the study database including routine revisions or additions to include the design and/or modification of routine and existing study database edit check programs for assigned studies
- Perform User Acceptance Testing (UAT) for assigned studies
- Monitor study data to ensure the quality and completeness of the data submitted by implementing quality control procedures
- Generate QC reports for site review and correction as well as a variety of other reports as required
- Evaluate study data for protocol compliance
- Maintain the documentation of the study database and other related data management programs and/or applications
- Ensure that Omeros meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP)
- Complete studies/projects ensuring completeness, documentation and storage
- Lead development of Omeros procedures and best practices as warranted
- Assist in the development and maintenance of standardization tools and training materials as requested
- Participate in the interview, evaluation and qualification of CDM candidates
- Mentor junior staff members and provide training based on specific expertise
What education and experience do you need?
- A 4-year degree (BA/BS) from a university ideally with a degree in a Life Science, Library Sciences or Computer Science
- 5+ years of experience as a CDM in Pharmaceutical or CRO setting
- Proficiency in the development and use of commercial EDC products (preference given for Medidata Rave/Balance/CTMS)
- Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle) favorable
- Proficiency in MS Office suite (incl. Word, Excel, PowerPoint)
- Knowledge of FDA regulations/ICH/ GCP/GCDMP guidelines
- Excellent written and verbal communication skills
Behavioral Competencies we are seeking:
- Excellent interpersonal skills
- Excellent project management and organizational skills in clinical trials setting
- Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates as well as vendors
- Demonstrated ability to develop and present varied and unique ideas
- Ability to display strong analytical and problem-solving skills; detail orientation required
Physical Demands Required:
- May encounter prolonged period of sitting
- The employee may frequently be performing repetitive movements such as typing on a keypad or using a mouse
- The employee may climb bend, reach, push, pull, balance, stoop, kneel, or crouch
- The employee must on occasion lift and/or move up to 20 pounds
- Possible travel, including overnight and international travel based on organizational and/or protocol specific need
If you have the experience, skills and knowledge we are seeking, we’d love to hear from you! This is an exciting opportunity for the right person!
Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.
It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000