When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
At Parexel people make the difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.
Our employees have the opportunity to do meaningful things globally while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential.
Parexel FSP is recruiting for a Clinical Trial Manager based in Spain.
Home based role. Dedicated to a single sponsor.
You will will manage individual oncology clinical trials and/or programs as part of the Clinical Trial Working Group.
Tasks on the role
Manage external vendors and contract research organizations
Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
Assist with protocol development and study report completion
Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
Provide guidance, direction, and management to CRAs
Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
Coordinate study supplies
Negotiate contracts with vendors of clinical trial services
Review Informed ConsentForms, CRFs, and study related materials
Plan and participate in investigator meetings
Assist and support data query process
Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines
Ensures trial master file is current and maintained
Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials.
Please note that responsibilities may require a work schedule that may include working outside of “normal” work hours, to meet business demands.
We expect from you:
Knowledge and Experience:
5 or more years of industry experience in clinical trial project management across international trials (Pharmaceutical, Biotech or CRO).
The ability to collaborate across teams and communicate clearly.
A patient‑focused mindset and strong attention to details.
Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device).
Proven experience of clinical trial management.
Proven management/leadership of people in a matrixed environment.
Demonstrated working knowledge of GCP, ICH guidelines and regulations, regulatory requirements, and clinical trial processes.
Demonstrated ability to work independently and in a team environment.
Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook).
Excellent oral and written communication skills and strong organizational abilities.
Strong experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans).
Strong experience of data management and query resolution in clinical trials.
Overall knowledge of site management and monitoring procedures.
Skills:
Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management.
Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities.
Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment
Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders.
Education:
Bachelor’s, nursing degree or equivalent required, science preferred.
We will offer you
Premium salary.
Attractive benefits.
Medical care plan: Health, Dental & Vision.
Life Assurance.
Excellent work environment.
Culture of teamwork and collaboration.
People who motivate and face challenges together.
Innovative technology.
Excellent training.
Expect exciting career challenges, but with a healthy work-life balance. We value your well-being as much as that of our patients.
For more details contact
Originally posted on Himalayas