Clinical Program Manager- Biomarker
333 Lakeside Dr. Foster City, CA 94404
Program Manager, Clinical Trials
Status: Full Time Employee
Location: Foster City, CA 94404
- Headquartered in the Bay Area
- One of the world’s leading bio-pharmaceutical companies focused on researching and developing advanced medical technology
- The company strives to simplify international care for all those affected by life-threatening illnesses
- Portfolio of highly successful output and over twenty marketed products
- Company spans six contents, employs over 8,000 people, and generates over $30 billion in revenue.
FEATURES AND BENEFITS:
- The company will offer you the opportunity to participate in the Employee Stock Purchase Plan, which allows you to contribute 1 to 15 percent of your salary to purchase stock at a discount, as well as the 401(k) plan with a matching contribution of 100%. They also offer a series of buses for ease of commute in the Bay Area. Opportunity to work from home up to two days a week, by manger discretion.
THE ROLE YOU WILL PLAY:
- Oversee successful biomarker strategy for clinical trials nationally and internationally
- Resolve matters using national and international regulations, guidelines and investigator interaction
- Build lasting relationships and rapport with internal and external stakeholders and serve as primary operations
- Evaluate scientific proposal and budget for clinical operation feasibility
- Determine possible operational challenges and provides solutions to ensure biomarker strategy stays on planned trajectory
- Maintain Biomarker Operations internal databases
- Demonstrate excellent management skills to create a collaborative environment
- Provides guidance and oversight for the successful management of all aspects of strategy implementation within assigned TA(s)
- Introduce, author or contribute to SOP protocol development, execution and training
- Write protocols, reports, regulatory documents related to clinical studies
- Demonstrate ability to successfully develop, implement, manage and complete clinical trials
- Serve as the primary operations contact with internal and external stakeholders
- Develop RFP’s and CRO/vendor selection
- Work within budget and timelines established, adjust and revise accordingly
- Strong understanding of FDA and/or EMA Regulations and relevant local regulations, ICH Guidelines, and GCPs related to clinical trials and non-interventional studies
- Performed and are proficient in all duties typical for a Sr. Clinical Trials Manager (Sr. CTM)/Clinical Operations position
- Excellent interpersonal and management skills
- Ability to participate and lead some strategic initiatives
- Minimum 6 years’ experience and a Bachelor’s or RN
ABOUT ABA SEARCH:
At ABA Search, we value professionalism, honesty, and hard work. We’re positive, innovative thinkers, and we use creativity to turn challenges into opportunities. We love to learn, and we continuously seek new ways to deepen our expertise. We’re energized by the legal industry, passionate about staffing, and committed to the success of our clients and candidates. That's what makes us “the name to know in recruitment.”
Director, Executive Search
Lauren’s first six years in recruiting started right here at ABA in the 1990s. In the 20+ years since, Lauren has been a staffing specialist at start-ups, an incubator, other staffing agencies, and she has served as the in-house recruiter for large international companies—not to mention running her own small business and raising three amazing children. Lauren’s breadth and depth of experience gives her a unique understanding of both client and candidate needs. To round out her knowledge, she has spent the last three years placing hardware and software engineering staff in the semiconductor industry as a Diversity Recruiter for Intel.
Some of Lauren’s past clients include Oracle, SAP, KPMG, PWC, Ernst and Young, Booz Allen Hamilton, boutique consulting firms, Fortune 500 companies, and start-ups where she placed technical, consulting, and sales staff. Her goal is to create enduring partnerships with candidates and clients alike, built on a rapport of honesty and trust. She has in-depth knowledge of all stages of the hiring/recruitment cycle and is skilled at advising selection criteria and managing job offer/compensation strategy. Most of all, Lauren absolutely loves recruiting because it’s not only challenging, but a great amount of fun too!
Born and raised in the Bay Area, Lauren graduated Summa Cum Laude from Dominican University with a B.S. in Human Resource Management and a minor in Psychology. Now located in Scottsdale, Arizona, she’s thrilled to be back with ABA where it all began to pursue the profession she loves.
Favorite things to do in Scottsdale: Exploring her new city and surrounding areas, hiking, and occasionally jumping on a plane to visit her college-aged daughter in the Northwest.
Favorite Quote: “This is the real secret of life – to be completely engaged with what you are doing in the here and now. And instead of calling it work, realize it is play.” - Alan Watts