Sr. Clinical Data Manager

Location
Seattle
Posted
Oct 23, 2020
Ref
1788
Discipline
Clinical, Clinical Data
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
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?

True innovation requires the right people, and that's what we have at Omeros - smart, hard-working and creative individuals who collaborate and drive to achieve what has not yet been done. We see strength in diversity - diversity in thought, expertise and experience.

We have taken a similar approach in structuring our company. While many bio-techs pursue a single therapeutic area or scientific platform, we are strategically building a deep and diverse pipeline of first-in-class small-molecule and antibody therapeutics. The strength of our scientific discoveries and exclusive intellectual property positions enable our pipeline programs to target highly promising receptors and enzymes that others have not been able to develop.

Although cutting across a wide and diverse range of disorders and therapeutic indications - some orphan, others large-market and many for which there are no approved treatments - all of our drugs on the market and in development target critical unmet needs to improve the lives of patients in meaningful ways.

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 studies
  • 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
  • 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
  • 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
  • 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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000