- Manages clinical and specialty CROs, Laboratories, and Clinical Trial Sites to successfully deliver high visibility, high impact clinical trials.
- Delivers crisp execution from planning to close-out to ensure adherence to timelines and goals while maintaining quality in accordance with FDA, EMEA, GCP, and ICH guidelines to deliver regulatory-grade data and outputs on time and within budget.
- Participates in authoring and reviewing study-related documents and plans such as Project Plans, Site Management Tools, Informed Consent, etc.
- Provides oversight for sample tracking and management across multiple labs in multiple geographies.
- Works collaboratively with internal and external cross-functional teams.
- Performs QC and oversight of CRO-housed Trial Master Files (TMFs) to ensure adequate and compliant study documentation.
- Minimum 5-7 years of experience in clinical trial operations as Sponsor. Relevant CRO or site experience is also valuable.
- Experience managing complex Phase I through III studies, preferably in oncology and rare diseases.
- Strong understanding of GCP/ICH and applicable regulations.
- Excellent interpersonal and communications skills (verbal and written), as well as problem solving and organization skills.
- Proven ability to work independently and proactively in a fast-paced environment while also exceling in cross-functional collaboration.
- Experience monitoring clinical studies and conducting and/or overseeing PSVs, SIVs, IMVs, and COVs is a plus as is data, sample reconciliation and management.
- Familiarity and aptitude on managing external spend is favorable.
- An interest in working alongside passionate, driven and fun teammates at a company rapidly evolving from Research into Development and beyond.
- A passion for making medicines patients need.
-
Director, Clinical Operations
1 week 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 ...
-
Director, Clinical Operations
1 week ago
Viridian Therapeutics Waltham, United StatesAt Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven ...
-
Director, Clinical Operations
4 days ago
Ophthalmic Consultants of Boston Waltham, United StatesJob Description · Job DescriptionOphthalmic Consultants of Boston (OCB) is recruiting for a Director, Clinical Operations. This multifaceted opportunity is 100% onsite. · Summary of Responsibilities: · The Director, Clinical Operations (Director) has overall responsibility for cl ...
-
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 ...
-
Director, Clinical Operations
1 week ago
Foghorn Therapeutics Inc. Cambridge, United StatesOur Culture: Why work with us? · At Foghorn Therapeutics, we believe in "People First, Mission Always." · We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that ...
-
Randstad Life Sciences US Cambridge, United StatesA major Pharmaceutical company, From accelerating drug discovery and early development to a rapidly expanding pipeline and a world-class team, delivering on the promise of treating infectious and other diseases. · SKILLS: · UNBLINDED study experience · Experience w/ IP documents ...
-
Director, Clinical Operations
1 week ago
Boston Pharmaceuticals Cambridge, United StatesCompany Overview · Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being ...
-
Clinical Operations Leader
1 week ago
Bill and Melinda Gates Foundation Cambridge, United States"We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcome ...
-
Director, Clinical Operations
1 week ago
Boston Pharmaceuticals Cambridge, United StatesCompany Overview · Boston Pharmaceuticals is a clinical-stage biopharmaceutical company. We are developing highly engineered targeted therapies for patients with serious liver diseases. Our lead investigational program, BOS-580, is a long-acting once-monthly FGF21 analogue being ...
-
Director, Clinical Operations
3 days ago
Foghorn Therapeutics Cambridge, United StatesJob Description · Job DescriptionOur Culture: Why work with us? · At Foghorn Therapeutics, we believe in "People First, Mission Always." · We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, ...
-
Associate Director Clinical Operations
5 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 ...
-
Manager, Clinical Laboratory Operations
1 week ago
BostonGene Waltham, United StatesJob summary · The Manager of Clinical Laboratory Operations will be responsible for performing and overseeing high complexity molecular testing according to established SOPs, including DNA and RNA extractions, NGS library preparation, hybridization-based enrichments, and next-gen ...
-
Manager, Clinical Laboratory Operations
1 week ago
BostonGene Waltham, United StatesJob summary · The Manager of Clinical Laboratory Operations will be responsible for performing and overseeing high complexity molecular testing according to established SOPs, including DNA and RNA extractions, NGS library preparation, hybridization-based enrichments, and next-gen ...
-
Senior Manager, Clinical Operations
2 days ago
Deciphera Pharmaceuticals Waltham, United StatesJob Description · Job DescriptionCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhib ...
-
The Steely Group Cambridge, United StatesReporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effectiv Clinical, Operations, Clinic, ...
-
The Steely Group Cambridge, United StatesJob Description · Job Description · Reporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing · instructions/information · from study managers or global project leaders to support Clinical Operations by ensuring the timely ...
-
director, clinical operations oncology
1 week ago
BioSpace Cambridge, MA, United StatesJob Details · The Role: · Moderna is seeking a Director of Clinical Operations to manage Oncology programs which may consist of one or more studies. This position will be responsible for initiating and leading clinical programs, inclusive of studies, across all phases, including ...
-
The Steely Group Cambridge, United StatesReporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effective implementation and maintenan ...
-
Associate Director, Clinical Operations
1 week ago
Clinical Dynamix, Inc. Cambridge, United StatesRole: Associate Director, Clinical Operations · We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing co ...
-
associate director, clinical operations
1 week ago
Moderna, Inc. Cambridge, MA, 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 ...
Clinical Trial Manager, Clinical Operations - Watertown, United States - Remix Therapeutics
5 days ago
Description
Remix 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 targets in diseases of high unmet medical need to bring new therapeutic options to patients. Remix has a commitment to demonstrate the highest levels of scientific integrity with urgency because those patients are counting on us to deliver. With an in-house technology platform built from scratch, we have rapidly generated multiple drug discovery programs that are advancing towards the clinic.Position Summary:
Remix seeks a high-energy and experienced individual with versatile skills specific to operational management and oversight of clinical trials. As Clinical Trial Manager (CTM) you will be responsible for the planning, management, budgeting, oversight, and overall execution of assigned clinical studies. This role will work closely with Clinical Development Leadership and across internal functions to provide input on key processes and infrastructure to ensure proper study oversight in a fully outsourced model for the first of many Remix Clinical Programs. The ideal candidate has played a critical role in managing global clinical trials with a solid understanding of good clinical practice and applicable regulatory requirements. You will be responsible for managing CROs and external vendors to execute global clinical studies which require concert amongst numerous sourcing partners and integration of complex data sets to support regulatory submissions and applications.
Principle Duties and Responsibilities:
Note to Third Party Staffing Agencies: Please do not forward any agency resumes. Remix Therapeutics is not responsible for any fees related to resumes that are unsolicited.
