- Serves as the key biomarker and bioanalytical operational (BBOps) contact with internal and external stakeholders, for successful implementation of biomarker and
- Participate in multiple Phase 1–4 clinical study teams
- Plans and coordinates all operational activities required with the collection, delivery and analysis of biological specimens within a clinical trial
- Provides sample management expertise to the Study Management Teams (SMTs), Biomarker SubTeams (BSTs), and Clinical Pharmacology Subteams (CPST)
- Accountable for ensuring biological samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed
- Primary interface for operational activities between the SMT and laboratory vendors; Provides the day–to–day operational management of vendors to ensure delivery
- Has ability to critically evaluate scientific proposal or protocol, and budget for clinical operation feasibility
- Establishes strong cross–functional relationships and exhibits strong leadership skills with counterparts in other functional teams (e.g., Biomarker Sciences, Vendor
- Proactively identifies potential operational challenges and in collaboration with senior team members provides resolution plans to ensure biomarker strategy remains
- Organizes and leads Biomarker and Bioanalytical operational meetings with study functional groups or vendors
- Maintains internal Biomarker and Bioanalytical Operations databases and document repositories
- Review of relevant documents including protocols, informed consents, and relevant study documents
- Must be able to understand, interpret and explain protocol requirements to others
- Assists in determining the activities to support a project's priorities within functional area
- Contributes to development of RFPs and participates in selection of CROs/vendors
- Able to examine functional issues from an organizational perspective
- May contribute or participate in special projects.
- Develops tools and processes that optimize project efficiencies and effectiveness.
- May contribute to development of abstracts, presentations and manuscripts
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Must have a general, functional expertise to support Process development and implementation
- Provides knowledge and expertise on country specific regulations
- Participates in and manages project meetings and conference calls with vendors and cross–functional teams.
- Develops tools and processes that optimize project efficiencies and effectiveness.
- Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.
- May be required to present at internal or external meetings (i.e., investigator meetings).
- Leads or otherwise assists in the preparation of interim and final study reports, including resolving any data discrepancies when biomarker data is needed for primary, secondary or support.
- Proactively identifies potential operational challenges and collaborates with other Clinical Operations' colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
- PharmD / PhD with 2+ years' relevant clinical or related experience in life sciences.
- MA / MS with 3+ years' relevant clinical or related experience in life sciences.
- BA / BS / RN with 5+ years' relevant clinical or related experience in life sciences.
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Ability to manage any component of full cycle study management, from start–up to close–out.
- Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
- Fully understands protocol requirements and effectively articulates and interprets these. Thorough knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
- Familiar with standard medical / scientific terminology.
- Experience managing the work of external vendors.
- Ability to communicate in a clear and concise manner.
- Ability to support a team–oriented, highly–matrixed environment.
- Ability to execute multiple tasks as assigned.
-
Senior Clinical Trial Manager
3 weeks ago
BioPhase California, United StatesBioPhase Solutions specializes in recruiting top talented professionals for Southern California's Life Sciences community. We are currently looking for an ONSITE Sr. Clinical Trial Manager to work for a leading San Diego area biotech company. · *Must be local to San Diego, CA. · ...
-
Clinical Trial Manager
3 weeks ago
Novozen Healthcare LLC California, United States· • Organizes and leads Biomarker and Bioanalytical operational meetings with study functional groups or vendors · • Maintains internal Biomarker and Bioanalytical Operations databases and document repositories · • Review of relevant documents including protocols, informed conse ...
-
Director Clinical Operations
5 days ago
BioPhase California, United StatesHybrid Position | Located in San Diego, CA · This Director of Clinical Operations will play a pivotal role in leading and supervising all activities related to clinical operations, including the management and execution of clinical trials in accordance with Good Clinical Practic ...
-
Sr eDiscovery Analyst
1 week ago
CTP California, United StatesJob Title: Sr eDiscovery Analyst · Location: San Francisco, Downtown LA, San Diego or Orange County. Hybrid. · Duration: FTE · The Company · Headquartered in Los Angeles, this Law Firm is a leader in the commercial real estate markets. With 240+ attorneys and a National presen ...
-
Director Clinical Operations
3 weeks ago
EPM Scientific California, United StatesDirector, Clinical Operations · $215,000-$240,000 · The biotechnology company is at the forefront of groundbreaking research in the field of Immuno-Oncology. They harness the power of the immune system to fight cancer, firmly establishing themselves as pioneers in this rapidly ev ...
-
Penfield Search Partners Ltd California, United StatesAssociate Director/Senior Manager, Oncology Biostatistics · Location: Hybrid SF or PA · Contact: Susan Devine - · Our client is a clinical-stage biotech company with an established track record and a strong pipeline in Oncology and Rare Disease, looking for an experienced Biosta ...
-
Trial and Supervising Attorney
2 weeks ago
Gordon Rees Scully Mansukhani, LLP California, United StatesTrial & Supervising Attorneys (6 years+ or more) · Gordon Rees Scully Mansukhani, LLP (GRSM) has immediate openings for civil litigation attorneys with a minimum of at least six years' experience practicing within the state of California and welcome experienced practitioners to a ...
-
Jazz Pharmaceuticals California, United States Full timeBrief Description: · The Associate Director, Clinical Data Innovation is responsible for overseeing all personnel, processes, and technologies that comprise the data and analytics platforms used by the Jazz Global Clinical Development Operations (GCDO) department. The two platfo ...
-
Senior Litigation Paralegal
3 weeks ago
Pathways Personnel California, United States PermanentOur client is an international law firm with a long established Bay Area presence. They have friendly energetic management that are accessible and always open to fresh ideas. They have a warm and inviting office culture that makes it fun coming to work. Our client is currently se ...
-
Global Clinical Trial Associate
3 weeks ago
PRA Health Sciences California, United StatesOverview · ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. · Positi ...
-
Manager, GCDO Business
3 weeks ago
Jazz Pharmaceuticals California, United States Full timeBrief Description: · The Manager, GCDO Business & Technology Capabilities demonstrates broad knowledge of the Clinical Development process and the technologies, systems, and applications that support this. The role is responsible for the design, development, production, delivery ...
-
Arias Sanguinetti | Trial Lawyers California, United StatesArias Sanguinetti | Trial Lawyers is hiring a Legal Assistant on our complex cases team, as well as two other trial teams. The Legal Assistant will assist attorneys in the areas with organizing internal files, saving mail and electronic documents, new file/client set up, records ...
-
Attorney
2 weeks ago
Edlin Gallagher Huie + Blum California, United StatesAttorney · There has never been a better time to join Edlin Gallagher Huie + Blum, a growing firm of nimble defense lawyers who help clients simplify the process of complex litigation. At EGHB, we serve as outside counsel for businesses, insurance companies, and the public sector ...
-
Clinical Development, Senior Director
5 days ago
Third Rock Ventures California, United StatesA clinical-stage biotechnology company based in San Francisco, backed by Third Rock Ventures, is harnessing the power of adipocyte biology and the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases. The company is b ...
-
Medical Malpractice Attorney
4 days ago
Manning Kass California, United StatesJoin Manning | Kass, a top-tier law firm with a proven track record of successfully defending individuals, and businesses of all sizes, from small family-run companies to Fortune 50 corporations, with extensive trial experience in state and federal courts and numerous successful ...
-
Sr. Trial Attorney
2 weeks ago
Nationwide Private Client California, United States Full timeIf you're passionate about being part of a diverse organization that enables a Fortune 100 company to deliver innovative business solutions with excellence, then Nationwide's Legal team could be the place for you At Nationwide, "on your side" goes beyond just words. Our customers ...
-
Partner/Counsel - General Liability
2 days ago
OneBridge Search California, United StatesProminent firm is growing and seeking to add a Senior Counsel or Partner level attorney for their Los Angeles office. Ideal candidate will have 7+ years of experience in one or more of the following practice areas: General Liability, Construction, Transportation, Premises Liabili ...
-
Litigation Counsel
5 days ago
Larson Maddox California, United StatesA reputable and growing client is seeking a strong litigation attorney to join the legal team. In this position, you will gain valuable litigation experience within practice areas of business litigation and transactions, employment matters, real estate and a variety of other doma ...
-
Director of Clinical Quality Assurance
2 weeks ago
GQR California, United StatesTitle: Director of Clinical Quality Assurance · Location: San Francisco, CA · Hybrid role, 2 days a week onsite · Status: Full-time direct hire · This position is a hands-on role tasked with ensuring that sponsored clinical trials comply with applicable GCP regulations (e.g., FDA ...
-
Lemon Law Attorney
2 weeks ago
Ascendion California, United StatesOur client is a reputable law firm specializing in Auto Fraud and Lemon Law litigation. With a track record of success, they are committed to providing top-notch legal representation to their clients in San Diego and beyond. They are currently seeking a skilled and experienced at ...
Clinical Trials Manager - California, United States - Mindlance
![Mindlance background](https://contents.bebee.com/companies/us/mindlance/background-PUHdd.png)
Description
FUNCTION:
Clinical Operations – Biomarker and Bioanalytical Operations
POSITION OVERVIEW:
Onsite In Foster City– Hybrid
Clinical Operations is responsible for the worldwide execution of all Phase I – IV clinical trials across all therapeutic areas.
Clinical Operations plays a key role in ensuring allclinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high–quality clinical data that supports
global registration and commercialization of 's products.
You will work with and collaborate with Clinical Operations, Biomarker Sciences, Clinical Pharmacology and other cross–functional team members. You will manage certain
components of clinical studies and act as a member of the study team. You will also manage biomarker and bioanalytical vendors. You will assist in the review of clinical study
protocols and other study documents, contribute to process development and/or participate in special projects. You may also participate in strategic initiatives.
EXAMPLE RESPONSIBILITIES:
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Minimum Education & Experience
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."