16 associate director clinical data management lead jobs found in Bernards, NJ

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks,...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards In this role, a typical day might include the following: Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects. Supervises direct DM reports for planning and managing all relevant DM activities within...

The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management activities and decisions including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. In this role, a typical day might include: Responsible for the overall success of the studies within a program(s) for Clinical Data Management (CDM). Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or...

We are seeking an Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Associate Director reports to the Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. As an Associate Director a typical day may include the following: May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist Contributes to program team meetings, scientific advisory boards, study...

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics with Global Development.  In this role, a typical day might include: ​ The incumbent will lead efforts of the Biostatistics department with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.  The incumbent will represent statistical issues in regulatory agency meetings.  The incumbent will lead the development and delivery of training to non-statistical colleagues, lead the development of new infrastructure and processes, and be active in representing the company in professional associations, conferences, and publications.  As an Associate Director, the incumbent will be responsible for...

The Senior Manager, Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training for direct reports that have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards In this role, a typical day might include the following: Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects. Supervises direct DM reports for planning and managing all relevant DM activities...

We are seeking an Associate Director for the Research and Pre-Clinical Development (R&pD) Lab Consumables team, specifically responsible for the Bioreagents subcategory creation, management, and execution. This role involves developing and leading strategies for our subcategories, as well as leading and implementing strategic sourcing initiatives. This role will coordinate the development of sourcing specifications, requirements, and scopes of work for RFIs, RFQs, and RFPs. They will gather and assess data through benchmarking, market intelligence reports, and Voice of the Customer (VoC) interviews, and perform analytics on spend, inventory levels, utilization, and KPI measurements. Additionally, delivering measurable cost savings for their category of spend. They will actively participate in supplier selection and relationship management, providing data-driven recommendations to management for informed decision-making. This role manages risk, develops strong business...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: MedTech Sales Job Sub Function: Technical Sales - MedTech (Commission) Job Category: Professional All...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

The Senior Medical Director, Clinical Sciences, Hematology provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program with minimal supervision from Program Lead MD. Clinical deliverables may include individual protocols consistent with the Clinical Development Plans (CDP); clinical components of regulatory documents/registration dossier and brand related medical information, clinical communications and publications. A day in the life may include the following responsibilities: Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates. Ensures timely execution of assigned clinical deliverables within approved budget. Supports Program Lead MD and frequently lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory...

We are seeking a Senior Manager, Global Procurement for the Research and Pre-Clinical Development (R&pD) Lab Consumables team. This role involves developing and building strategies for our subcategories, as well as planning and driving strategic sourcing initiatives. This role will develop sourcing specifications, requirements, and scopes of work for RFIs, RFQs, and RFPs. They will gather and assess data through benchmarking, market intelligence reports, and Voice of the Customer (VoC) interviews, and perform analytics on spend, inventory levels, utilization, and KPI measurements. Additionally, this person will deliver measurable cost savings and monitor these savings against contracted terms and pricing. They will actively participate in supplier selection and relationship management, providing data-driven recommendations to management for informed decision-making. The Senior Manager will also manage risk and contribute to the development of junior team members. They will work...

We are seeking a Global Procurement Manager for the Research and Pre-Clinical Development (R&pD) Lab Consumables team. This role involves developing and managing strategies for our subcategories, as well as planning and driving strategic sourcing initiatives. The Manager will be responsible for developing sourcing specifications, requirements, and scopes of work for RFIs, RFQs, and RFPs. They will gather and assess data through benchmarking, market intelligence reports, and Voice of the Customer (VoC) interviews, and perform analytics on spend, inventory levels, utilization, and important metric measurements. Additionally, the Manager will deliver measurable cost savings and monitor these savings against contracted terms and pricing. They will actively participate in supplier selection and relationship management, providing data-driven recommendations to management for informed decision-making. The Manager will work collaboratively with teammates and cross-functional partners...