Edc Project Manager Jobs in Seattle, WA (NOW HIRING)

Description
ASSOCIATE DIRECTOR, CLINICAL DATA MANAGEMENT
JOB SUMMARY
TheAssociateDirector,Clinical Data Managementwill leadData Management for multiple clinical studies and/or a clinical development program. Reporting to theSenior Director, Clinical Operations,theincumbent will provide leadership and guidance for all phases of clinical studies from the EDC study design through to study closeout andbe responsible forthe oversight and management of clinical data management activities outsourced to CROs.
KEY ROLES AND RESPONSIBILITIES

• Responsible for the oversight of Clinical Data Management deliverables, including activities outsourced to CROs to ensure adherence to the protocol, the scope of work and service agreements, ensuring high quality and integrity of all deliverables.
• Ensure CRO adherence to project timelines, from study startup through study closeout.
• Collaborate with clinical study teams and vendors to ensure project deliverables are met with clinical study data acquisition, quality data review, and reporting in compliance with GCP, SOPs, and regulatory requirements.
• Develop Data Management metrics and key performance indicators to aid in the oversight and management of CRO partners.
• Serve as primary point of escalation for CRO for data management
• Lead internal data review for assigned clinical studies.
• Identify and mitigate risk to data integrity driving for timely resolution.
• Assist in identifying data trends and report on performance and quality
• Develop requirements/specifications for outsourcing data management to vendors. Works with Program Management team for review of vendor proposals, contracts, scope changes / change orders, and budgets for accuracy with respect to data management activities.
• Perform reconciliation of vendor invoices for accuracy as needed
• Participate in vendor qualification visits and audits.
• Lead or contribute to the development, review, and implementation of Clinical Data Management processes, policies, and SOPs.
• Proficiencyin, and ability to learn, new clinical systems including EDC, IWRS/IRT/RTSM, CTMS, eTMF and other clinical project management toolsrequired.
• Lead data management study inspection readiness activities and support of submission activities as needed.
• Train and mentor DM staff or internal team members on processes, projects, systems, and programs.
• Perform hands-on data management responsibilities, ifrequired.
• Other activities may be assigned asrequired

REQUIRED QUALIFICATIONS

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).
• Minimum of 8 years clinical trial experience in the pharmaceutical, biotech industry, clinical trial site, or CRO
• Experience managing a CRO, including quality and performance oversight
• Experience in the set-up and management of third-party vendors.

PREFERRED QUALIFICATIONS

• Experience with phase global phase III clinical trials for a biotechnology company, preferably with Vaccines.
• Experience in Industry Standards for Case Report Form development (i.e., CDISC/CDASH).
• Familiarity with SDTM and Adam models
• Experience with Medidata Rave (EDC) is preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• Thorough knowledge of FDA, CFR and ICH GCP requirements and other regulatory requirements.
• Ability to communicate technical concepts clearly and concisely to non-technical colleagues.
• Strong organizational skills, attention to detail, and self-motivated.
• Team player, withtheability to work successfully across functions.
• Can thrive in a fast-paced environment with rapid change while effectively managing pressure in a professional manner.
• Flexibility in work hours as needed to accommodate international collaborators or significant meetings/events.

PHYSICAL DEMANDS
Performing the responsibilities of the job requires ability to use hands and fingers to handle or feel and to manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Ability to read and type while sitting in front of a computer up to 4 hours at a time. Vision abilities required by this job include close vision. May occasionally have to lift, tug, and pull up to 25 lbs.
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Curevo offers its employees a generous range of compensation and benefits.
The salary range for this position is $190,000 - $205,000 annually. The salary range may vary based on Curevo's compensation practices and an applicant's qualifications and experience.
Employees have the opportunity to earn an Annual Discretionary Bonus, as well as being eligible to participate in Curevo's Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect. We have a Flexible Vacation Plan, a Paid Sick Leave Plan, and earn 1 hour of sick time for every 30 hours worked, plus 10 paid holidays per year.
At Curevo, we believe the highest-performing teams include people from diverse backgrounds and experiences who respectfully challenge one another and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.
About Curevo Vaccine
Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.
Attention: Search Firms / 3rd Party Recruitment Agencies
The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated should we hire from unsolicited resumes.
Recruiters are requested not to contact or present candidates directly to our hiring managers or employees and doing so may jeopardize eligibility to work on future positions.