- As part of the regional leadership team, provides inspirational leadership, proactive management, and feedback-oriented mentorship to clinical study managers at various levels for assigned portfolio and may lead a designated therapeutic area or asset
- Accountable for regional study or portfolio delivery with appropriate inspection readiness quality, within agreed timelines and budget
- May act as regional lead (if needed) for one or multiple studies across an indication or across a program as required.
- Leads regional clinical operations teams (including external partners working on a regional level) and acts as point of escalation for resolution of issues within the region for the assigned portfolio of studies.
- Ensures alignment of regional resources and deliverables with overall portfolio goals.
- Creates an environment that fosters innovation of regional tools and leads the development of work instructions and SOPs as required.
- Drives deliverables regionally for trial or portfolio
- Influences improved standards of quality and efficiency for the region, promoting subject matter, disease area, or asset level expertise.
- Strategically leads the regional clinical operations team effectively across the department, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study.
- Collaborates with key stakeholders in the region and provides regular updates on portfolio progress in the region to senior management and Global Clinical Study Manager as required.
- Champions high-impact, cross-departmental teams within and across the region to ensure different perspectives, ideas and expertise are reflected when executing clinical trials
- Develops, refines, and articulates regional goals, inspiring performance across teams, and develops cross-functional strategies that lead to portfolio success.
- Displays therapeutic area knowledge and expertise of assigned portfolio and encourages individuals across the region to aspire to develop this expertise.
- Oversees the planning and management of the assigned clinical studies from feasibility through closeout activities for region, in line with global study timelines.
- Influences regional leaders to generate, manage, and maintain high quality study start up and recruitment timelines for region and tracks their progress to plan.
- Shapes and influences strategies to ensure that the clinical studies are operationally feasible in the region, optimizes trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders.
- Provides regional input on global study plans that refine their templates.
- Drives a feedback-oriented culture, in which regional study managers are held accountable for effective coaching and mentoring CRAs to ensure proper study execution at the sites.
- Sets clear quality expectations and priorities for the regional study management and strategies to achieve these expectations.
- Anticipates potential concerns and resolves escalated issues or problems with the sites in region in close collaboration with stakeholders such as country heads.
- Monitors study activities in region to ensure compliance with study protocol, SOPs, ICH/GCP and all other relevant regulations.
- Ensures inspection readiness for studies in region at any point in time throughout the study life cycle.
- Engages effectively across the regional leadership to ensure cross-team, site learnings, and best practices are shared, promoting awareness and cross-functional collaborations.
- Improves workload management by supporting clinical study managers in setting priorities and by postponing less relevant work
- Leads the development, optimization and review of work instructions and SOPs as required.
- Demonstrates understanding of the department's business levers that impact financial goals, and employs that knowledge to make critical business decisions for the department that support the region's financial goals
- Works with the sourcing team to strategize regional study vendor needs.
- Works closely with Clinical Business Operation on optimizing efficiency related to investigator fees, site payment issues and patient travel reimbursement activities.
- Strategically forecasts regional team resource needs and establishes contingency plans for key resources.
- Optimizes regional resource utilization over study lifecycle and liaises with functional managers as needed.
- As part of the regional leadership team:
- Interviews, line manages, and evaluates performance of regional clinical study managers (rCSMs)
- Will support regional strategy and provide input on resourcing assignments
- Provides key input on annual operating plan, headcount, and budget
- Communicates with FSP partners
- Inspires individuals across the business unit to perform at their best; encourages others to recognize their contributions toward the success of the business unit and stay motivated
- Ensures the competencies and skills required for the regional Clinical team are consistent with the company defined requirements.
- Develops and implements effective coaching and mentoring processes that can be customized to support both junior team and senior team members and supporting their professional development plans.
- Conduct performance appraisals for direct reports which includes providing feedback.
-
Hematology-Oncology
1 week ago
Hayman Daugherty Associates, Inc San Jose, United StatesJob Overview · Seeking Hematology-Oncology physicians for a permanent job in CA · Radiation in-house, pharmacy in-house, 13-14 infusion chairs from 8 am to 6 pm · Clinic is open Monday - Friday, 8-5pm for the clinic and infusion is open form 8-6pm. (possibility of 4 days and then ...
-
Medical Assistant, Hematology Oncology
2 days ago
Sutter Health Sunnyvale, United States**Organization**: · PAMF-Palo Alto Medical Foundation CAD · **Position Overview**: · Provides clinical and clerical support to providers and members of the patient care team(s) by performing a variety of back office and patient-related tasks supporting the delivery of high-qualit ...
-
Hematology/Oncology - Neurology
3 weeks ago
Kaiser Permanente - The Permanente Medical Group, Inc. -Northern California Redwood City, CA, United StatesThe Permanente Medical Group, Inc., (TPMG) is one of the largest medical groups in the nation with over 9,500 physicians, 22 medical centers, numerous clinics throughout Northern and Central California and a 75-year tradition of providing quality medical care. · TPMG is recruit ...
-
Hematology/Oncology - Neurology
3 weeks ago
Kaiser Permanente - The Permanente Medical Group, Inc. -Northern California Redwood City, United States Full timeThe Permanente Medical Group, Inc., (TPMG) is one of the largest medical groups in the nation with over 9,500 physicians, 22 medical centers, numerous clinics throughout Northern and Central California and a 75-year tradition of providing quality medical care.TPMG is recruiting f ...
-
Medical Assistant, Medical Oncology/hematology
2 weeks ago
Sutter Health Palo Alto, United States**Organization**: · PAMF-Palo Alto Medical Foundation PAD · **Position Overview**: · Provides clinical and clerical support to providers and members of the patient care team(s) by performing a variety of back office and patient-related tasks supporting the delivery of high-qualit ...
-
Medical Assistant, Hematology Oncology, Travel
3 weeks ago
Sutter Health Mountain View, United States**Organization**: · PAMF-Palo Alto Medical Foundation CAD · **Position Overview**: · Provides clinical and clerical support to providers and members of the patient care team(s) by performing a variety of back office and patient-related tasks supporting the delivery of high-qualit ...
-
Medical Assistant- Oncology/hematology- Fremont
3 weeks ago
Sutter Health Fremont, United States**Organization**: · PAMF-Palo Alto Medical Foundation ALD · **Position Overview**: · Provides clinical and clerical support to providers and members of the patient care team(s) by performing a variety of back office and patient-related tasks supporting the delivery of high-qualit ...
-
Pediatrics Hematology/Oncology
3 weeks ago
Kaiser Permanente - The Permanente Medical Group, Inc. -Northern California Oakland, United States Full timeTPMG is seeking a full-time BE/BC Pediatric Hematology/Oncology physician to join our team in Oakland, CA. · We are currently seeking a 6th BC/BE Pediatric Hematologist/Oncologist to join our growing pediatric specialty group in Oakland, California. The position is a 10/10th full ...
-
Hematology/Oncology Physician
1 week ago
DocCafe San Jose, United StatesDocCafe has an immediate opening for the following position: Physician - Hematology/Oncology in San Jose, California. · Make $ - $1/hourly. · DocCafe is the premier physician and advanced practice job board to help you advance your healthcare career. · Register now to apply for t ...
-
Stanford Hematology/Oncology
1 week ago
University Medical Partners San Jose, United States· Position at University Medical Partners · Hematology/Oncology Physician (Full-time) · University Medical Partners Stanford Medicine · San Jose, CA · University Medical Partners (UMP), a partner of Stanford Medicine, is seeking a full-time BC/BE Medical Hematologist/Oncologist ...
-
Hematology Medical Oncology
3 weeks ago
The Permanente Medical Group, Inc. - Nrnia Richmond, CA, United States Full timeTPMG is recruiting full-time Hematologist/Oncologist Physicians to join our team in Oakland, CA. · Excellent opportunity for a full-time BE/BC physician in Hematology or both Hematology and Oncology. We are looking for someone with a strong background in malignant hematology; so ...
-
Pediatrics Hematology/Oncology
3 weeks ago
The Permanente Medical Group, Inc. - Nrnia Berkeley, CA, United States Full timeTPMG is seeking a full time BE/BC Pediatrics Hematology/Oncology physician to join our team in Oakland, CA, · The position is a 10/10th full-time position (FTE 1.Responsibilities for this clinical position include attending in inpatient and outpatient pediatric settings, consult ...
-
Hematology/Oncology Physician
1 week ago
DocCafe San Francisco, CA, United StatesDocCafe has an immediate opening for the following position: Physician - Hematology/Oncology in San Francisco, California. · DocCafe is the premier physician and advanced practice job board to help you advance your healthcare career. · Register now to apply for this job and for a ...
-
Hematology/Oncology Specialist
2 weeks ago
University of California , San Francisco San Francisco, United States· Application Window · Open date: June 8, 2023 · Most recent review date: Wednesday, Apr 24, 2024 at 11:59pm (Pacific Time) · Applications received after this date will be reviewed by the search committee if the position has not yet been filled. · Final date: Sunday, Dec 8, 202 ...
-
Hematology-Oncology Physician
2 weeks ago
MDstaffers San Jose, CA, United StatesMDstaffers is seeking a qualified Hematology-Oncology Physician in San Jose, CA . For more information, please apply or call 90-STAFF. · Job Description · A Hematology-Oncology Physician is needed in San Jose, CA to join a group that is dedicated to providing care to the co ...
-
RN- Oncology/Hematology
3 weeks ago
The National Coalition of Healthcare Recruiters San Francisco, CA, United States2000(Only QUALIFIED Healthcare Professionals accepted) Oncology- RN - Cancer Center Infusion Location: San Francisco · 13 week travel assignment - ASAP · Adult- Oncology- RN Needed · Travel Needs - ASAP · RN's – Acute Care/Hospital · Skills/Experience (2 yrs each) · • Adult ...
-
Hematology Medical Oncology
1 week ago
The Permanente Medical Group, Inc.-Kaiser Permanente Oakland, CA, United StatesThe Permanente Medical Group, Inc., TPMG is one of the largest medical groups in the nation with over 9,500 physicians, 22 medical centers, numerous clinics throughout Northern and Central California and a 75-year tradition of providing quality medical care. · (TPMG) is recruiti ...
-
Pediatrics Hematology/Oncology
3 weeks ago
Kaiser Permanente - The Permanente Medical Group, Inc. -Northern California Oakland, United States Full timeTPMG is seeking a full-time BE/BC Pediatric Hematology/Oncology physician to join our team in Oakland, CA.We are currently seeking a 6th BC/BE Pediatric Hematologist/Oncologist to join our growing pediatric specialty group in Oakland, California. The position is a 10/10th full-ti ...
-
Hematology and Medical Oncology
2 weeks ago
The Permanente Medical Group, Inc. - Nrnia Pinole, CA, United States Full timeThe Permanente Medical Group, Inc., (TPMG) is recruiting for a full-time Hematologist/Oncologist to join our team in Oakland, CA · KP Oakland is a tertiary care center within KP with all major subspecialties represented on campus. Our group is seeking a BC/BE hematologist/oncolo ...
-
Hematology Medical Oncology
3 weeks ago
The Permanente Medical Group, Inc. - Nrnia Pleasanton, CA, United States Full timeThe Permanente Medical Group, Inc., (TPMG) is one of the largest medical groups in the nation with over 9,500 physicians, 22 medical centers, numerous clinics throughout Northern and Central California and a 75-year tradition of providing quality medical care. · TPMG is recruiti ...
Senior Director, Regional Clinical Study Management Hematology/ Oncology - San Mateo, United States - BeiGene
Description
General Description:
Essential Functions of the job:
Regional Leadership
Timelines, Planning and Execution
Quality
Budget and Resources
Supervisory Responsibilities:
Education & Experience Required: Bachelor's degree in a scientific or healthcare discipline and 12+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry. Preferably master's degree in a scientific or healthcare discipline and 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
