Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.
As a Senior Clinical Data Manager you will oversee, lead, manage and provide technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate and timely manner to the Sponsor’s satisfaction.
Position Accountabilities/Responsibilities:
- Provide fully independent and autonomous leadership of data management services (start up, conduct and close out) across multiple complex global projects/programs, including:
- Ensure appropriate resources are allocated to complete all DM activities on time and budget.
- Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs).
- Ensure effective UAT is performed.
- Write external vendor reconciliation specifications for programming reconciliation outputs (e.g. Serious Adverse Events, IRT, Central Laboratory).
- Oversee data cleaning activities.
- Produce metrics to monitor progress of trial activities.
- Ensure all database lock activities are completed on time.
- Represent WorldWide DM at both internal and external study meeting calls, including providing input.
- Monitor project scope, budgets and risks and alert DM Management of any concerns.
- Liaise with DM Management at regular intervals to discuss progress and any issues outstanding (e.g. during Project Review Meetings).
- Collaborate with internal Worldwide departments working on the same project.
- Provide feedback on process improvements to DM Management and/or SMEs.
- Participate in and lead process reviews.
- Provide training, support and mentorship to other members of the DM department.
- Participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Other skills and abilities:
- Excellent attention to detail.
- Excellent written and verbal communication skills.
- Strong knowledge of data management best practices & technologies as applied to clinical trials.
- Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams.
- Strong understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
- Strong analytical and problem solving skills.
- Independent and autonomous project oversight skills.
Requirements/Qualifications:
- Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline — or equivalent relevant experience.
- Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.