Senior Manager Associate Director of Clinical Data Management

Location

Berkeley, CA | United States

Job description

Job description

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve antitumor activity. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T and CAR-NK platforms as readily available treatments for patients with hematologic malignancies and solid tumors.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

Our fun and collaborative Clinical Development team is seeking an innovative and highly motivated Senior Manager / Associate Director of Clinical Data Management with a background in leading end-to-end data management activities. Reporting to the Senior Director of Clinical Data Management, you will be responsible for delivery on clinical databases, execution of clinical data deliverables and providing data management expertise to the team. This position is hybrid or remote.

Responsibilities include:

• Lead end-to-end clinical data management activities within the study team and represents data management on internal and external cross functional teams
• Lead and oversee the vendor in data management activities including database build, data review, and database lock, following requirements defined in the clinical protocol and in alignment with industry best practice guidelines and Caribou Clinical Development data standards and processes
• Draft, review and finalize data management documents, coordinating input with the clinical study team including the Data Management Plan, eCRF specifications, eCRF Completion Guidelines, Coding Guidelines, Data Transfer Specifications, and Data Review Plans
• Coordinate coding schedule and coding review to fulfill reporting requirements
• Perform Query Quality Control for vendor performance and data quality oversight; reviews clinical data to ensure data collection is of high quality and completed per protocol specifications
• Collaborate with cross-functional team members on achieving overall clinical development milestones and timelines including dose review meetings, abstracts/publications, internal/external meetings, and interim/primary analyses
• Lead or support audits and Health Authority inspections
• Contribute to/participate in data management initiatives and innovation by supporting development of data management procedures and contributing to non-project initiatives

Qualifications:

• Bachelor’s degree and 5+ years (Senior Manager) / 7+ years (Associate Director) of experience in clinical data management from start up to final database lock    
• Experience in oncology drug development across different study phases
• Strong experience of EDC systems, especially Medidata Rave
• Successful experience managing vendor relationships
• Strong knowledge of FDA and ICH/GCP regulations and industry standards applicable to data capture and overall data management process
• Effective oral and written communication skills; excellent interpersonal skills
• Attention to detail and commitment to high quality and on-time deliverables
• Ability to prioritize and handle multiple tasks simultaneously and strong organizational skills
• Team oriented and collaborative

Additional Requirements:

• Availability during normal business hours in the employee’s time zone
• Availability to travel to Caribou Biosciences meetings in California and other study related meetings as needed (~5% travel)

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $145,000 - $190,000. This represents the present low and high end of the Company’s pay range for this position. Actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance.
• Generous paid vacation time, in addition to company-observed holidays and floating holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

For more information about Caribou, visit www.cariboubio.com and follow the company @CaribouBio.ß

Please mention the word **PREFERES** and tag RMzQuMjIxLjUyLjE1MQ== when applying to show you read the job post completely (#RMzQuMjIxLjUyLjE1MQ==). This is a beta feature to avoid spam applicants. Companies can search these words to find applicants that read this and see they're human.

Job tags

Salary

$50k - $86.25k