- Provide leadership to study teams & make recommendations in strategic aspects of clinical programs
- Leads the creation of initial study budgets with input from cross functional leads and acts as the primary point of contact with finance and leadership team throughout the life of the study.
- Establish and continuously monitor/update the global study timelines and budgets, including all internal functional areas, vendors, CROs, and promptly escalating significant risks or changes
- Serve as primary Operations contact for internal and external study team members on assigned studies/projects and as the escalation point for investigators and sites
- Lead the selection of CROs, consultants, and vendors including identifying potential vendors and developing proposal requests
- Oversee CRO and/or vendor activities and coordinate cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to site selection, study start-up, recruitment, study conduct, and database lock and study close-out
- Lead cross-functional development of and adherence to study specific operational plans, and processes ensuring clear roles, responsibilities, and communication pathways. Plans and processes may be developed in collaboration with vendors including plans for vendor oversight, project management, communication, recruitment, monitoring, and risk management. These will ensure studies are conducted efficiently, effectively, and in accordance with the protocol, GCP/ICH guidelines, federal regulations, and applicable SOPs.
- Contribute to development of plans and documents led by other functions such as data management and data review plans, statistical analysis plan, safety management plan, etc
- Track and report on the overall status of assigned clinical trials including enrollment metrics, key performance indicators (e.g., deviations, trial risks, monitoring metrics), milestones, timelines, and budgets
- Continuously assess risks to study performance, timelines, budgets and proactively plan risk mitigation strategies
- Organize and participate in meetings, i.e., Study Team, Trainings, Investigator, and Scientific
- Review and/or directly contribute to study documents such as vendor specifications, study manuals, training materials, site and patient facing materials, CRFs, monitoring reports, special correspondence, communication plans, etc.
- Contribute to protocols, clinical study reports, annual reports, key safety reports, and regulatory documents
- Lead quality reviews of study conduct, including TMF and monitoring report reviews, and lead inspection readiness activities for both internal sponsor audits and health agency audits (FDA, Health Canada, etc)
- Perform ongoing assessment of operational efficiency and communication and adjust study processes to ensure high team performance
- Review and/or write SOPs for Clinical Operations and Clinical Development, update and maintain SOPs, and participate in departmental improvement initiatives
- Direct or indirect management and oversight of CTA and/or junior COLs
- Contribute to management decisions on project team resourcing needs and strategy
- Perform other duties as assigned
- Education: Bachelors' degree in science or nursing
- Experience: Minimum of 10 years of clinical research experience, with minimum of 6 years trial management experience in industry (sponsor or CRO) At least 5 year of vendor management experience is required. Experience with oncology, neurology and/or radiopharmaceuticals required
- Preferred: Masters' degree (MBA, MS or MPH) or PMP certification. Experience with monitoring oversight or direct monitoring preferred.
- Possess highly effective interpersonal and analytical skills enabling influencing and negotiation skills
- Strong problem solving and decision-making skills
- Strong understanding of clinical trial methodology, drug development process, ICH-GCP guidelines and applicable regulatory requirements is required
- Experience in clinical program management, and clinical operations management of clinical trials
- Well organized and detail oriented with strong written and verbal communication skills
- Highly proficient in MS Office applications
- Let people be their best
- Respect one another and act as one
- Learn, adapt, and win
- Know someone's health is in our hands
- Own the solution and make it happen
-
Clinical Operations Manager
2 weeks ago
Access Vascular Billerica, United StatesJob Description · Job DescriptionJob Summary · As the Clinical Operations Manager, you will be a pivotal force in overseeing clinical trials, ensuring regulatory compliance, and driving successful trial execution. Your role involves close collaboration with research teams, extern ...
-
Associate Director Clinical Operations
6 days ago
Meet Waltham, United StatesTitle: Associate Director, Clinical Operations - Rare Disease/Oncology Background Needed · Location: Waltham, MA (Onsite 2 Days Weekly) · Key Responsibilities: · Lead and oversee the execution of clinical trials within the rare disease and oncology therapeutic areas. · Develop an ...
-
Associate Director, Clinical Operations
3 weeks ago
Ventus Therapeutics Waltham, United StatesAbout us: · Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology. · Our proprietar ...
-
Head of Clinical Operations
2 weeks ago
Cellarity Somerville, United StatesWhat if you could join a company rapidly advancing its first candidate molecule to clinic and play a critical role in bringing new medicines to patients through looking at and treating disease in a revolutionary way? · What if you could be the first hire in Clinical Operations wi ...
-
Clinical Operations Analyst
2 weeks ago
Medasource Cambridge, United States ContractApply Now · << Clinical Operations Analyst · Boston, Massachusetts (Hybrid) · 1 year contract with likelihood of extension · Project Goal & Overview: · Our client is seeking a highly experienced Senior Clinical Analyst to lead and execute enterprise initiatives for clinical opera ...
-
Clinical Operations Manager
6 days ago
BioSensics Newton, United StatesDescription · BioSensics is a biomedical engineering firm specializing in wearable medical sensor and telehealth technologies. Our physiological monitoring, telehealth, and biofeedback products are used in elderly care, physical therapy, rehabilitation, orthopedics, neurology, an ...
-
Director, Clinical Operations
6 days ago
Kymera Therapeutics, Inc. Watertown, United StatesWho we are: · Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients' lives. Kymera is deploying TPD to address ...
-
Clinical Trial Manager, Clinical Operations
5 days ago
Remix Therapeutics Watertown, United StatesRemix launched with a vision to transform patient's lives through modulation of RNA processing. Our breakthrough science provides a path to identify small molecules that impact the expression of disease driving mRNAs and proteins. We take on the challenge of addressing drug targe ...
-
Director, Clinical Operations
1 day ago
Corbus Pharmaceuticals Norwood, United StatesWe are seeking a Director, Clinical Operations to provide strategic leadership and operational planning expertise to Corbus Pharmaceuticals clinical development programs. We are looking for an experienced Clinical Program Manager who can lead the creation and high-quality impleme ...
-
Senior Director, Clinical Operations
2 weeks ago
Kiniksa Pharmaceuticals Lexington, MA, United StatesReporting to the VP, Clinical Operations & Medical Writing the Sr. Director will ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards. The Sr. Director will ensure that the appropriate company infrastructure and ...
-
Head of Clinical Operations
4 days ago
Cellarity Somerville, United StatesWhat if · you could join a company rapidly advancing its first candidate molecule to clinic and play a critical role in bringing new medicines to patients through looking at and treating disease in a revolutionary way? · What if · you could be the first hire in Clinical Operat ...
-
Director, Clinical Operations
3 weeks ago
Third Harmonic Bio Cambridge, United StatesAbout Third Harmonic Bio · Third Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation - debilitating conditions that can take a significant toll on overall health and well-b ...
-
Associate Director Clinical Operations
2 weeks ago
Leap Therapeutics Cambridge, United StatesPlease note that this role is hybrid and based in Cambridge, MA. It requires a weekly onsite in office schedule. Full time remote work will not be considered. · Company Summary · Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. ...
-
Director, Clinical Operations
1 week ago
Vor Biopharma Inc. Cambridge, United StatesWho we are looking for: · Vor Bio is seeking a highly motivated Director, Clinical Operations to join our fast-paced, dynamic team at this exciting phase of our Clinical Development Program. · Key areas of responsibility: · * Executes the day-to-day operations of clinical trials ...
-
Associate Director Clinical Operations
2 days ago
Meet Boston, United StatesAre you an experienced Clinical Operations professional looking to advance your career in a dynamic and innovative environment? Do you thrive in a fast-paced setting and excel at managing clinical trials from start to finish? If so, we have an exciting opportunity for you to join ...
-
Clinical Operations Coordinator
4 weeks ago
Outcomes4Me Boston, United States FreelanceJob Description · Job DescriptionClinical Operations Coordinator - Contractor · (12-18 months, with potential to become a full-time position) · Outcomes4Me uses AI and machine learning to help cancer patients navigate their care and access personalized treatment information. Whe ...
-
Assistant Manager Clinical Operations
5 days ago
Yale New Haven Health Groton, United States Full timeOverview · To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and pr ...
-
Director, Clinical Operations
3 weeks ago
Ophthalmic Consultants Of Boston Waltham, United StatesOphthalmic Consultants of Boston · Director, Clinical Operations · Waltham , · Massachusetts · Apply Now · Ophthalmic Consultants of Boston (OCB) is recruiting for a Director, Clinical Operations. This multifaceted opportunity is 100% onsite. · Summary of Responsibilities: · ...
-
Associate Director, Clinical Operations
1 week ago
Moderna Theraputics Cambridge, United StatesThe Role: · Moderna is seeking an Associate Director of Clinical Operations to manage rare disease studies. This consist of more than one study. This position will be responsible for initiating and leading clinical studies, across all phases, including overseeing CROs and vendors ...
-
Director, Clinical Operations Excellence
5 days ago
Nuvalent Inc. Cambridge, United StatesThe Company: · With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with ...
Associate Director, Clinical Operations - Bedford, United States - Lantheus
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
Summary of Role
The Associate Director, Clinical Operations leads the planning, execution and conduct of complex clinical programs while adhering to budget, scope and timelines. The AD, Clinical Operations is responsible for managing all aspects of multiple clinical trials with emphasis on CRO, vendor and internal team management to drive a high functioning and results- driven team including timeline adherence, patient safety, adherence to contracted deliverables, the protocol(s), appropriate regulations, and data integrity.
The role is expected to provide leadership within the department and to make recommendations with regards to the strategic aspects of Clinical Operations deliverables, timelines, budgets, and resourcing. The incumbent must have a demonstrated capacity to lead with minimal supervision, communicate effectively, think strategically, motivate a team and drive results.
Key Responsibilities/ Essential Functions
The ideal candidate will embody Lantheus core values:
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
