Senior Clinical Research Associate
2 weeks ago
Purpose
Describe the primary goals, objectives or functions or outputs of this position.
To enable AbbVie' s emergence as a world class R&D organization, the position plays a key role in ensuring successful protocol level execution of SMM deliverables involving start-up, execution, and close-out of studies.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out. Ensure site related study execution including but not limited to monitoring visits, site evaluations, site selection, and activation, and monitoring close out and visit reports. Anticipate and identify site issues that could affect timelines and develop alternative solutions.
- Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements.
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies.
- Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site audits/inspections; provide input into the CAPA preparation.
- Responsible for coaching and mentoring CRAs and providing input into their development. Responsible for mentoring CRAs for various aspects of work.
- May be responsible for being the country point of contact for CROs for an assigned study.
May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager. - If assigned; Responsible for identifying training needs and standardizing and facilitating training solutions for SMM monitors globally. Provide consistent best practice approach to onboarding, consolidating "lessons learned" across areas and incorporating into monitoring training materials, defining best practice training curriculum, and maintaining awareness of upcoming changes to ensure effective training is delivered in a timely manner.
- If assigned; With guidance, may serve as key point of contact in country/district for assigned study. Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc.
- If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials.
- If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site monitors.
Qualifications
List required and preferred qualifications (up to 10). Include education, skills and experience.
- Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
- Site Monitoring Experience: Minimum 3 years.
- Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making.
- Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity. Demonstrated proactive and positive team player.
- Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadlines.
- Demonstrated business ethics and integrity.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
-
Clinical Research Associate II
2 weeks ago
Shanghai, Shanghai, China PSI Full timeJob Description As a Clinical Research Associate II at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. You will: Conduct and report SSV, SIV, RMV, COV onsite monitoring visits Perform CRF review, source document verification...
-
Associate Director, Clinical Research
1 month ago
Shanghai, Shanghai, China MSD Full timeJob DescriptionMain ResponsibilityThe clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration. The clinical research physician is expected to address issues/questions raised.Whenever Clinical Research designs a clinical study, the clinical research...
-
Associate Director, Clinical Research
2 weeks ago
Shanghai, Shanghai, China MSD Full timeJob DescriptionMain ResponsibilityThe clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration. The clinical research physician is expected to address issues/questions raised.Whenever Clinical Research designs a clinical study, the clinical research...
-
Associate Director, Clinical Research
4 weeks ago
Shanghai, Shanghai, China MSD Full timeJob DescriptionMain ResponsibilityThe clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration. The clinical research physician is expected to address issues/questions raised.Whenever Clinical Research designs a clinical study, the clinical research...
-
Clinical Research Associate II
2 weeks ago
Shanghai, Shanghai, China AbbVie Full timeJob DescriptionMonitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to...
-
Manager, Clinical Research
2 weeks ago
Shanghai, Shanghai, China MSD Full timeJob DescriptionChina Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important mission of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of...
-
Manager, Clinical Research
3 weeks ago
Shanghai, Shanghai, China MSD Full timeJob DescriptionChina Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important mission of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of...
-
Manager, Clinical Research
1 month ago
Shanghai, Shanghai, China MSD Full timeJob DescriptionMain ResponsibilityThe clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration. The clinical research physician is expected to address issues/questions raised.Whenever Clinical Research designs a clinical study, the clinical research...
-
Manager, Clinical Research
4 weeks ago
Shanghai, Shanghai, China MSD Full timeJob DescriptionMain ResponsibilityThe clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration. The clinical research physician is expected to address issues/questions raised.Whenever Clinical Research designs a clinical study, the clinical research...
-
Manager, Clinical Research
4 weeks ago
Shanghai, Shanghai, China MSD Full timeJob DescriptionMain ResponsibilityThe clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration. The clinical research physician is expected to address issues/questions raised.Whenever Clinical Research designs a clinical study, the clinical research...
-
Senior Advisor, Clinical Research
2 weeks ago
Shanghai, Shanghai, China Lilly Full timeWe're looking for people who are determined to make life better for people around the world. This job is under Lilly China Drug Development and Medical Affair Center (LCDDMAC) for Diabetes, Obesity, and Metabolic area, one of the strategic therapeutic areas of Lilly China. The Clinical Research Physician will take core medical role as scientific leader in...
-
Associate Director, Clinical Compliance, JAPAC
2 weeks ago
Shanghai, Shanghai, China AbbVie Full timeJob DescriptionResponsible for compliance with applicable Corporate and Divisional policies and procedures.Provide tactical and strategic oversight of clinical trials to ensure compliance across all TherapeuticAreas/ Clinical OperationsDevelop and assess cost, resource projections and metrics for the functionIntegral participant during regulatory inspections...
-
Associate or Senior Editor, Nature Medicine
2 weeks ago
Shanghai, Shanghai, China Springer Nature Group Full timeAbout Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For over 175 years our brands and imprints have been a trusted source of knowledge to these...
-
Associate Clinical Affairs Manager
2 weeks ago
Shanghai, Shanghai, China Philips Full timeJOB DESCRIPTION Job Title Associate Clinical Affairs Manager Job Description In this role, you have the opportunity to · Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs; · Lead the clinical evaluation projects across the product lines, work...
-
Senior Clinical Scientist
1 month ago
Shanghai, Shanghai, China Philips Full timeJob TitleSenior Clinical ScientistJob DescriptionIn this role, you have the opportunity toCarry out industrial research, enlarging relevant knowledge and bringing-in new knowledge. Representing a relevant competency of the group and developing oneself in line with Group strategy.You are responsible forDesigning and conducting clinical studies with Philips...
-
Senior Clinical Scientist
2 weeks ago
Shanghai, Shanghai, China Philips Full timeJob TitleSenior Clinical ScientistJob DescriptionIn this role, you have the opportunity toCarry out industrial research, enlarging relevant knowledge and bringing-in new knowledge. Representing a relevant competency of the group and developing oneself in line with Group strategy.You are responsible forDesigning and conducting clinical studies with Philips...
-
Senior Clinical Scientist
4 weeks ago
Shanghai, Shanghai, China Philips Full timeJob TitleSenior Clinical ScientistJob DescriptionIn this role, you have the opportunity toCarry out industrial research, enlarging relevant knowledge and bringing-in new knowledge. Representing a relevant competency of the group and developing oneself in line with Group strategy.You are responsible forDesigning and conducting clinical studies with Philips...
-
Senior Scientist, Clinical Pharmacology
2 months ago
Shanghai, Shanghai, China Johnson & Johnson Full timeObjective of Position The Therapeutic Area (TA) Clinical Pharmacology (CP) Senior Scientist role within Clinical Pharmacology and Pharmacometrics (CPP) is to apply clinical pharmacology knowledge, including design of clinical pharmacology studies or clinical pharmacology component of clinical studies, pharmacokinetics/ pharmacodynamics analyses and...
-
Senior Clinical Scientist
1 month ago
Shanghai, Shanghai, China Philips Full timeIn this role, you have the opportunity toCarry out industrial research, enlarging relevant knowledge and bringing-in new knowledge. Representing a relevant competency of the group and developing oneself in line with Group strategy.You are responsible for Designing and conducting clinical studies with Philips strategic customers; Trans-modality clinical...
-
Senior Clinical Scientist
4 weeks ago
Shanghai, Shanghai, China Philips Full timeIn this role, you have the opportunity toCarry out industrial research, enlarging relevant knowledge and bringing-in new knowledge. Representing a relevant competency of the group and developing oneself in line with Group strategy.You are responsible for Designing and conducting clinical studies with Philips strategic customers; Trans-modality clinical...
